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CADTH Health Technology Review
Authors; Calvin Young, and Quenby Mahood.
Amputation is the surgical removal or loss of a body part due to injury or disease. Common reasons for amputation include trauma, cancer, peripheral vascular disease, severe infection, neuropathy, and complications of diabetes.1,2 While they may be considered medically necessary to control disease or prevent mortality, lower limb amputations are associated with mobility issues, psychological distress, and decreased quality of life.3,4
In Canada, the annual rate of lower limb amputation is approximately 25 people per 100,000.5,6 While amputation impacts people of any age, sex, or gender, the incidence of lower limb amputation is disproportionally higher in males and those older than 75 years.5,6 Care related to amputation, rehabilitation, and the long-term management of people with lower limb amputation is associated with significant use of health care resources.6-9
Postoperative care that aims to maximize mobility, enables activities of daily living, and controls comorbid conditions is important to the rehabilitation process in people with lower limb amputation.4,10 Once surgical wounds have sufficiently healed, it may be appropriate to initiate prosthesis fitting. There are many different approaches to prosthesis fitting that can be considered, particularly when designing the prosthetic socket. The socket is the interface between the individual’s residual limb and the prosthesis, and can be above or below the knee, depending on whether the amputation was transfemoral or transtibial. Proper fit of the socket is critical, as inappropriate fit can cause pain, stress, skin irritation or breakdown, and pressure sores.11 Achieving optimal socket fit is challenging as the shape and size of the residual limb fluctuates as it matures due to muscle atrophy, post-operative edema, and residual limb muscle activity.12
One strategy to potentially increase socket fit is to use interim prosthetic sockets (also known as test sockets, check sockets, or preparatory sockets) that can be adjusted and modified based on user feedback. Typically made of thermoplastic materials that are readily adjustable by prosthetists, interim sockets can be used in the recovery phase to enable early mobilization.13,14 Once the surgical wound is completely healed and the residual limb has stabilized to a more permanent shape, a definitive socket (also known as a permanent socket) intended for long-term use can be designed and manufactured based on the changes made to the interim socket.13
Clinicians and policy-makers may be faced with complex decisions regarding the use of multiple prosthetic sockets for people with lower limb amputations. To ensure these decisions can be made in consideration of the available evidence, the objective of this report is to summarize the published literature regarding the clinical effectiveness of multiple prosthetic sockets for people with lower limb amputations. Additionally, evidence-based guidelines that provide recommendations regarding the use of multiple prosthetic sockets for people with lower limb amputations will be reviewed.
A limited literature search was conducted by an information specialist on key resources including Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Database of Systematic Reviews, the international HTA database, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were amputation, lower limbs, prosthetics, and sockets. A CADTH-developed search filter was applied to limit retrieval to guidelines for a secondary search for the concepts amputation, lower limbs, and prosthetics. The search was conducted on May 24, 2022, and limited to English-language documents published since January 1, 2012.
A supplementary literature search was conducted to address additional research questions related to the use of prosthetic sockets in people with lower limb amputation that were outside the scope of this Rapid Review. The methodology and findings of this search are available in Appendix 6.
One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.
Selection Criteria.
Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published before 2012. Guidelines with unclear methodology were also excluded.
The included publications were critically appraised by 1 reviewer using the following tools as a guide: the Downs and Black checklist15 for non-randomized studies and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument16 for guidelines. Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.
A total of 519 citations were identified in the literature search. Following screening of titles and abstracts, 490 citations were excluded and 29 potentially relevant reports from the electronic search were retrieved for full-text review. Eight potentially relevant publications were identified from the grey literature for full-text review. Of these 37 potentially relevant articles, 35 publications were excluded for various reasons, and 2 publications that met the inclusion criteria were included in this report. These comprised 1 non-randomized study17 and 1 evidence-based guideline.18 Appendix 1 presents the PRISMA19 flow chart of the study selection.
Additional references of potential interest are provided in Appendix 5.
One non-randomized study17 and 1 evidence-based guideline18 met the selection criteria and were included in this review. No relevant health technology assessments, systematic reviews, or randomized controlled trials (RCTs) were identified. Detailed study characteristics are provided in Table 2 and Table 3 in Appendix 2.
The non-randomized study17 was a single-centre, retrospective cohort study. The study was carried out between January 2016 and May 2017.
The evidence-based guideline18 was developed by a group of Dutch researchers affiliated with various institutions in the Netherlands, led by the Netherlands Society of Physical and Rehabilitation Medicine. The guidelines were informed by evidence retrieved using systematic searches in 5 electronic databases, including the Cochrane Library, Medline, Embase, PsycINFO, and CINAHL. The systematic searches were supplemented by manual literature searches. The searches were conducted up to January 2011 and were limited to articles published in Dutch, English, German, and French. Eligible study designs varied by topic and were dependent on the types of available literature (e.g., if robust systematic reviews or RCTs were available, data from observational studies were not considered). The individual studies were assigned a level based on their methodological quality between A1 (higher quality) and D (lower quality). Recommendations were assigned a level of evidence using EBRO (Dutch evidence-based guideline development) criteria. Levels of evidence ranged between level 1 (based on a systematic review of at least 2 independent, high-quality RCTs or at least 2 independent, high-quality RCTs with consistent results) and level 4 (based on expert opinion). A clear description of the methods used to formulate recommendations (e.g., consensus, voting) was not provided.
The retrospective cohort study17 was conducted in Turkey. The guideline18 was assumed to be intended for use in the Netherlands.
The retrospective cohort study17 included data from 88 individuals, between the ages of 18 and 70 years, who received a lower limb prosthesis for transtibial or transfemoral amputation at the study centre, had used their prosthesis for at least 6 months, and who underwent lower limb amputation for acquired reasons. People who had bilateral lower limb amputation or who underwent lower limb amputation due to reasons such as tumours, congenital anomalies, infections, burns, and poliomyelitis, were excluded. The mean age of study participants was 40.31 years in the test socket group and 38.89 years in the no test socket group. The proportion of female participants was 38.6%. Mean body mass index was 26.05 kg/m2 in the test socket group and 25.97 kg/m2 in the no test socket group. Of the 88 participants, 63 (71.6%) had transtibial amputation and 25 (28.4%) had transfemoral amputation. The time since amputation and the reasons for amputation were not reported.
For the included guideline,18 the target population is people with lower limb amputation. The intended users of the guideline18 are clinicians involved in providing care for people with amputation and prostheses of the lower extremity.
Participants of the retrospective cohort study17 were divided into 2 groups: those who received a test socket and those who did not receive a test socket. The test sockets were temporary sockets used shortly after amputation. While the test socket resembled the permanent (i.e., definitive) socket, they were manufactured using thermoplastic material that could be adjusted based on user feedback. Once a final shape was obtained, the permanent socket was designed according to the changes made to the test socket. Participants in the no test socket group had a permanent socket designed without the use of a test socket.
The guideline18 made recommendations on a wide range of interventions that can be provided to individuals through the post-amputation rehabilitation process (e.g., physical therapy, psychological therapies, exercise), including prostheses. Relevant to the current report, there are recommendations specific to interim prostheses that can be used in the early postoperative phase, before the fitting of a definitive prosthesis.
The retrospective cohort study17 reported on various measures of clinical effectiveness, including measures of mobility and function, pain, depressive symptoms, participant satisfaction, and other clinical outcomes (i.e., prosthesis delivery time, frequency of admissions to the study clinic).
Measures of mobility and function included duration of daily prosthesis use, daily walking distance with prosthesis, time to complete a 10-metre walk test on a flat surface, time to complete a 10-step climbing up test, time to complete a 10-step climbing down test, time to complete a 10-metre walking up an 8% slope test, and time to complete a 10-metre walking down an 8% slope test.
Pain was assessed at rest and while walking using the visual analogue scale (VAS). Participants were asked to indicate their level of pain on a 10 cm scale that ranged from 0 (no pain) to 10 (very severe pain).17 The VAS tool is widely used to assess pain in research and has shown promising validity in many clinical settings and patient populations.20-22
Depressive symptoms were measured using the Beck Depression Inventory (BDI). The BDI is a 21-question multiple-choice self-report inventory where each answer is rated on a 4-point scale ranging from 0 to 3. A total score is calculated by adding the values from each item.17 Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. Like the VAS, the BDI is widely used in research and has promising validity in many patient populations.23-25
Participant satisfaction was assessed with the Turkish version of the Trinity Amputation and Prosthetic Experience Scales (TAPES). The TAPES contains 3 subscales, including:
The Turkish version of the TAPES has demonstrated validity and reliability in Turkish people with unilateral lower limb amputation (i.e., the population examined in the retrospective cohort study).17,26
Additional clinical outcomes assessed in the retrospective cohort study17 included prosthesis delivery time and frequency of admission to the study clinic within 3 months. Clear descriptions of these outcomes were not provided. For prosthesis delivery time, it was assumed that this was the time between initial prosthesis measurement and final delivery, but this was unclear. Similarly, the authors reported on the frequency of admissions to the study clinic within 3 months, but it was unclear what time frame was being evaluated (e.g., whether it was the 3 months following amputation or prosthesis delivery, or another time frame).
The authors of the included guideline18 appeared to consider many different outcomes when formulating recommendations relevant to the current report, including time to final prosthesis fitting, edema, measures of mobility, risk for complications, and time to complete stump healing, as these were the outcomes summarized from the cited literature.
The methodological quality of the included studies17,18 is presented here. Additional details regarding the strengths and limitations of the included publications are provided in Appendix 3, Table 4 and Table 5.
The methodological quality of the retrospective cohort study17 was assessed using the Downs and Black checklist.15 The study17 had clearly described objectives, intervention, comparator, outcomes, and main findings. Additionally, the authors clearly described the patient eligibility criteria (i.e., inclusion and exclusion criteria), reported estimates of random variability (e.g., standard deviations), and provided exact P values (rather than simply reporting whether a result was statistically significant or not). Baseline demographic data, such as age, gender, weight, height, body mass index, education level, occupation, and type of amputation, were described and were tested for statistically significant differences between intervention groups. For all these demographic characteristics, there were no statistically significant differences between those who received a test socket and those who did not. Robust reporting of these study characteristics and results increases the reproducibility of the study. Additional methodological strengths were that compliance with the assigned intervention was reliable, outcome measures were valid, and authors declared their sources of support (i.e., departmental sources) and that they had no potential conflicts of interest. Finally, the study participants, care providers, and care settings appeared to be representative of the population and care setting of interest, increasing the external validity of the study.17
As for methodological limitations, assignment of patients to receive a test socket or no test socket was not done at random. It is possible that prognostic factors, patient preference, and clinician discretion were factors in determining which treatment participants received, increasing the risk of bias due to confounding. Additionally, the timing of outcome assessment was poorly reported. It was unclear how much time had passed between prosthesis fitting, with or without a test socket, and outcome measurement. It was possible that the timing of outcome measurement was not consistent between treatment groups, potentially leading to biased results (i.e., if some participants had more time to adjust to their definitive prosthesis, they may have performed better on tests for mobility and physical function). It was also unclear whether the outcomes reported in the study17 were all collected as part of routine follow-up assessments and retrieved from medical records, or if some outcomes were measured after initiating the study. Furthermore, participants and outcome assessors of the retrospective cohort study17 were aware of the intervention received by the participant; therefore, there was a risk of bias in either direction depending on the perceptions and expectations of those involved, particularly due to the subjective nature of the assessed outcomes. There was a lack of reporting of adverse events, and it was unlikely that all important adverse events that may have been a consequence of the intervention (e.g., skin ulcers, blisters) were recorded. Additionally, the authors of the study17 conducted tests for statistical significance for many outcomes without adjustment for multiplicity. Therefore, there may be potential type I error rate inflation. The findings of the study are also at risk for reporting bias as the authors did not register a protocol outlining their intentions before completing the study. Finally, the generalizability of the findings from the retrospective cohort study17 to Canadian settings was unclear given it was conducted at a single centre in Turkey.
Overall, the non-randomized study17 was of low methodological quality due to the limitations related to study design, poor reporting, and risk of bias due to confounding and other sources.
The methodological quality of the guideline18 was assessed using the AGREE II instrument.16 The guideline18 provided clear descriptions of its scope, objective, target population (i.e., people with lower limb amputation), and target users (i.e., clinicians involved in providing care for people with amputation and prostheses of the lower extremity). The name, affiliated institution, and geographic location of the authors were provided; however, the professional discipline or area of expertise of each author and their role in the guideline development group were not reported. Therefore, it was unclear if individuals from all relevant professional groups were consulted while drafting the recommendations. Similarly, while the authors stated that important aspects such as patient preferences, financial costs, and potential facilitators and barriers of applying recommendations were considered when drafting the guidelines, the methods used to incorporate these considerations were not reported. It was unclear what impact these considerations may have had on the recommendations. The authors used systematic methods to search for evidence to inform their recommendations, considered the benefits and risks of various interventions when drafting recommendations, and there was an explicit link between the recommendations and the supporting evidence. These methodological strengths increase the credibility of the recommendations. However, there was a lack of reporting on the criteria for selecting studies (e.g., there was limited description of inclusion and exclusion criteria, it was unclear if studies were screened in duplicate), the methods used for formulating the recommendations, and the procedure for updating the guideline. As a result, the reproducibility of the guideline18 is low. Furthermore, the guideline18 did not include a description of facilitators and barriers to guideline application, advice or tools on how the recommendations can be put into practice, and did not present monitoring or auditing criteria, decreasing the usability of the guideline.18 Finally, the guideline18 appeared to have editorial independence as the authors declared that they had no conflicts of interest and the views of the funding body (i.e., the Quality Foundation of Dutch Medical Specialists) did not seem to have any influence on the content of the guidelines.
The overall findings of the included studies are highlighted in the following text. Detailed summaries of the main findings by outcome are available in Appendix 4 (Table 6 to Table 11).
The retrospective cohort study17 found that participants with transtibial or transfemoral amputation who used a test socket before final prosthesis fitting had increased painless daily walking distance, took less time to complete a 10-step climbing up test, and took less time to complete a 10-metre walk test up an 8% slope at follow-up when compared to those who did not use a test socket before final prosthesis fitting. There were no statistically significant differences between participants with transtibial or transfemoral amputation in the test socket and no test socket groups for other measures of mobility and function at follow-up, including duration of daily prosthesis use, time to complete a 10-metre walk test on a flat surface, time to complete a 10-step climbing down test, and time to complete a 10-metre walk test down an 8% slope.
Participants in the test socket group who had transtibial or transfemoral amputation experienced statistically significantly less pain while walking at follow-up (measured with the VAS) compared to participants in the no test socket group of the retrospective cohort study.17 There were no significant differences in resting pain (measured with the VAS) between the test socket and no test socket groups in people with transtibial or transfemoral amputation at follow-up.
Findings from the retrospective cohort study17 suggested that there were no statistically significant differences in depressive symptoms (measured with the BDI) at follow-up between participants with transtibial or transfemoral amputation in the test socket and no test socket groups.
Participant satisfaction was assessed in the retrospective cohort study17 using the TAPES. According to the results for each of the TAPES subscales, participants with transtibial or transfemoral amputation in the test socket group had higher psychosocial adjustment, lower physical activity restriction, and higher prosthesis satisfaction than participants in the no test socket group at follow-up.
The authors of the retrospective cohort study17 concluded that participants with transtibial or transfemoral amputation in the test socket group had a lower frequency of admissions to the study clinic within 3 months but had longer mean prosthesis delivery times.
The guideline18 included 3 relevant recommendations related to the use of multiple prosthetic sockets for people with lower limb amputation.
The first recommendation stated that the postoperative use of (interim) prosthesis as soon as possible after transtibial amputation appears to result in fewer complications and revisions and a shorter time to fitting of the final prosthesis. The authors considered the findings of 4 comparative studies evaluating the effect of the timing of prosthesis fitting when formulating this recommendation.
The second recommendation stated that universal interim prostheses are less suitable for first provision, as they are not optimally adapted to the specific situation of the patient’s stump. This recommendation was based on expert opinion, as no evidence to inform this statement was identified.
The third recommendation stated that a custom-made prosthesis (not necessarily the final prosthesis) provided as early as possible in the postoperative phase is preferable to universal prefab prosthesis. This recommendation was based on expert opinion, as no evidence to inform this statement was identified.
There was no evidence identified related to the use of multiple prosthetic sockets in people younger than 18 years or older than 70 years; thus, the clinical effectiveness of multiple prosthetic sockets in children and older adults was unclear. This is an important limitation given the high incidence of lower limb amputation in people older than 70 years.5,6
A limited quantity of evidence addressing the clinical effectiveness of multiple prosthetic sockets for people with lower limb amputations was identified. The clinical evidence summarized in this review was from 1 retrospective cohort study17 that included a limited number of participants (88 individuals). The identified evidence has limited generalizability. For example, the included retrospective cohort study17 examined 1 protocol for the use of a temporary test socket before designing and manufacturing the permanent socket in people with transtibial or transfemoral amputation. The clinical effectiveness of this protocol is not likely representative of all multiple prosthetic socket protocols used to manage people from the time of amputation to the final prosthesis fitting, as these protocols may be highly variable. Additionally, the retrospective cohort study17 was conducted in Turkey, and the applicability of its findings to Canadian settings is unclear.
The authors of the retrospective cohort study17 did not describe minimal clinically important difference values for any outcomes measured using questionnaires, tools, or scales (e.g., pain assessed using the VAS, depressive symptoms assessed using BDI scores). It was unclear if any of the reported statistically significant differences in outcomes assessed using these measures translate into clinically meaningful differences.
The relevant recommendations from the included guideline18 were based on low-quality evidence or expert opinion, due to the absence of research addressing the authors’ topics of interest. Additionally, no recommendations were identified regarding the optimal number of sockets that should be provided during the preparatory and definitive prosthesis treatment phases.
This review identified 1 non-randomized study17 and 1 evidence-based guideline18 regarding the use of multiple prosthetic sockets for people with lower limb amputation.
Findings from the low-quality non-randomized study17 suggested that people with lower limb amputation who use a temporary test socket to inform the design of the permanent prosthesis may experience improvements to some measures of mobility and function (i.e., painless daily walking distance, time to complete a 10-step climbing up test, time to complete a 10-metre walk test up an 8% slope), less pain while walking, increased prosthesis satisfaction, and fewer clinic admissions compared to those who are fitted for their permanent prosthesis without the use of a test socket. There were no statistically significant differences between participants who received a test socket and participants who did not receive a test socket for the remaining outcomes examined in the study,17 including severity of depressive symptoms, resting pain, and certain measures of mobility and function (i.e., duration of daily prosthesis use, time to complete a 10-metre walk test on a flat surface, time to complete a 10-step climbing down test, and time to complete a 10-metre walk test down an 8% slope). The evidence-based guideline18 recommends the postoperative use of a prosthesis as soon as possible after transtibial amputation. In addition, the guideline18 recommends custom-made prostheses (not necessarily the final version) over prefab prostheses as early as possible in the postoperative phase.
The limitations of the included literature should be considered when interpreting the findings of this report. These limitations include the low quality of the non-randomized study17 and of the evidence informing relevant recommendations from the guideline;18 the unclear clinical significance of the statistically significant between-group findings from the non-randomized study;17 and the paucity of literature on children, older adults, and from Canadian settings. Future higher-quality research is warranted to address some of the knowledge gaps regarding the clinical effectiveness of multiple prosthetic sockets that are identified in this review. Additional evidence-based guidelines, particularly those intended for use in Canadian settings, may be helpful to clinicians and policy-makers involved in providing care for people with lower limb amputation and for whom multiple prosthetic sockets may be appropriate.
Appraisal of Guidelines for Research and Evaluation
Beck Depression Inventory
randomized controlled trial
Trinity Amputation and Prosthetic Experience Scales
visual analogue scale
Selection of Included Studies.
Characteristics of Included Non-Randomized Study.
Characteristics of Included Guideline.
Note that this appendix has not been copy-edited.
Strengths and Limitations of the Non-Randomized Study Using the Downs and Black Checklist.
Strengths and Limitations of the Guideline Using AGREE II.
Note that this appendix has not been copy-edited.
Summary of Findings by Outcome — Mobility and Function.
Summary of Findings by Outcome — Pain.
Summary of Findings by Outcome — Depression.
Summary of Findings by Outcome — Participant Satisfaction.
Summary of Findings by Outcome — Other Clinical Outcomes.
Summary of Relevant Recommendations in Included Guideline.
Note that this appendix has not been copy-edited.
Note that this appendix has not been copy-edited.
A customized supplement to this report is provided to help inform health care decision-making and addresses a specific set of questions that may be of potential interest but were out of scope for the review.
A targeted literature search was conducted by an Information Specialist in Medline, Cumulative Index to Nursing and Allied Health (CINAHL), Scopus, as well as a focused Internet search. The search was completed on June 8, 2022 and was limited to English language documents published since January 1, 2017.
One reviewer screened literature search results (titles and abstracts) and selected publications that potentially addressed the research questions. Full texts of study publications were not reviewed.
Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
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