Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2005-03-31

Brief Summary

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People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.

Detailed Description

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The traditional assumption when fabricating a transtibial amputee (TTA) socket is that the residual limb is not homogeneous in its ability to tolerate load. As a result, prosthetic sockets are currently fabricated by modifying a positive mold to account for this non-homogeneity; these are called rectified sockets. Unrectified sockets retain the shape of the residual limb, except for a distal end pad. Unrectified sockets use an alginate gel method of fabricating that is simpler and less time consuming than the method used to fabricate rectified sockets. This study will compare patient satisfaction and function with rectified and unrectified sockets.

Participants in this study will be randomized to either a recitified socket group or an unrectified socket group. Participants will wear the socket for a minimum of 4 weeks. Participants will then fill out a Prosthesis Evaluation Questionnaire (PEQ). The PEQ quantifies patient satisfaction by evaluating nine validated scales. Functional measures of energy expenditure, kinematics, and ground reaction forces during gait will also be collected. After 4 weeks, participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket. At the end of 4 weeks with the new socket, participants will once again fill out the PEQ and undergo functional assessment. At the end of study participation, each participant will freely choose the socket they wish to have in their final prosthesis.

Thus far, 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks. Results indicated no differences between sockets for gait speed and timing, gait kinematics and kinetics, gait energy expenditure, and Rate of Perceived Exertion (RPE). There were also no differences in the Prosthetic Evaluation Questionnaire. Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket.

Conditions

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Amputation

Keywords

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Transtibial amputees Rectified sockets Unrectified sockets Gait Energy expenditure Prosthetic evaluation questionnaire

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Unrectified prosthetic socket

Intervention Type DEVICE

Rectified prosthetic socket

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral transtibial amputation
* Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
* Continuously worn a prosthesis for at least 1 year prior to study entry
* Scheduled for a new prosthesis
* Independent ambulation
* No acute health problems

Exclusion Criteria

* Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
* Requires gel inserts, additional ply socks, or other atypical fitting components or methods
* Health status that prohibits patient from performing graded exercise test

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jack R. Engsberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Jack R. Engsberg

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Engsberg JR, Sprouse SW, Uhrich ML, Ziegler BR, Luitjohan FD. Comparison of Rectified and Unrectified Sockets for Transtibial Amputees. J Prosthet Orthot. 2008;18(1):1-7. doi: 10.1097/00008526-200601000-00002.

Reference Type BACKGROUND

PMID: 18776945 (View on PubMed)

Other Identifiers

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R01HD038919-02

Identifier Type: NIH

Identifier Source: org_study_id

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