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Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis (AS-TT)

2026년 5월 13일 업데이트: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation.

The AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility.

This multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Background. Lower-limb amputation affects more than 7,500 people annually in France, with approximately 50% at the transtibial level. The socket is the critical interface between the residual limb and the prosthesis, transmitting mechanical forces while needing to remain comfortable. Currently, only RS (carbon or resin) are listed on the French reimbursable products list (LPPR) for transtibial amputation. Documented limitations of rigid sockets include restricted knee flexion, walking discomfort in challenging environments, donning difficulties, and suboptimal pressure distribution that does not adapt to residual-limb volume changes.

Investigational device. The AS follows the same molding and shaping principles as the standard RS but differs in two manufacturing steps: (1) carbon fibers are placed only on lateral, postero-inferior, and inferior areas to provide structural rigidity; (2) stratification uses urethane resin (ProtheFLEX®, already used in medical-device manufacturing) instead of epoxy or acrylic resin, creating soft zones in regions typically rigid in conventional sockets.

Comparator. Both sockets are manufactured from the same plaster mold to ensure strictly identical internal geometry. Only the material structure (carbon/urethane distribution) differs; all other prosthetic components (intermediate piece, prosthetic foot) are identical.

Design rationale. A double-blind design is not feasible because participants can perceive differences in socket rigidity and prosthesis weight. The crossover design controls for between-subject variability and order effects.

Sample size. Based on the preliminary study (Patient Specific Functional Scale (PSFS) standard deviation 1.74), to detect a difference of 1.3 points (the PSFS MDC₉₀ for 3 items) with 80% power and α=0.05, 19 participants are required. 25 will be enrolled to account for dropouts and to provide a more representative sample for secondary endpoints.

Visits. Four study visits over approximately 14-21 weeks per participant: inclusion (V0), evaluation after first socket period (V1), evaluation after second socket period (V2), and an optional follow-up visit (V3) one month later if the participant elects to keep the AS.

연구 유형

중재적

등록 (추정된)

25

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Clamart, 프랑스, 92140
        • 모병
        • Hôpital National d'Instruction des Armées (HNIA) Percy
        • 수석 연구원:
          • Marie Thomas-Pohl, MD
        • 연락하다:
      • Freyming-Merlebach, 프랑스, 57804
        • 모병
        • Hôpital Filieris de Freyming-Merlebach
        • 연락하다:
        • 수석 연구원:
          • Catherine Achour
      • Grenoble, 프랑스, 38434
        • 모병
        • CHU Grenoble Alpes - Hôpital Sud
        • 연락하다:
        • 수석 연구원:
          • Solène MAret, MD
        • 부수사관:
          • Phillipe Escobar, MD
      • Nancy, 프랑스, 54000
      • Paris, 프랑스, 75007
        • 모병
        • Insititution Nationale des Invalides
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Unilateral or bilateral transtibial amputation
  • Currently fitted with a definitive carbon rigid socket
  • Any residual-limb shape
  • Any etiology
  • Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read/write autonomously
  • Provided free written informed consent
  • Aged 18 years or older
  • Affiliated to a social security system

Exclusion Criteria:

  • Use of hydroalcoholic solution (HAS) for socket donning
  • Currently fitted with a provisional socket
  • Neurological pathology limiting capacity to participate in activities
  • Orthopedic pathology limiting capacity to participate in activities
  • Pregnant or breastfeeding women
  • Minors
  • Persons not under legal protection or unable to express consent
  • Persons under guardianship or curatorship
  • Persons under judicial protection

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Group 1 (RS -> AS)
Participants wear their standard rigid socket (RS) for 4 weeks, complete evaluation, then switch to the Access Socket (AS) for 1-2 weeks of adaptation followed by 4 weeks of wear, with a second evaluation.
장치: Access Socket (AS)
Hybrid prosthetic socket combining a rigid carbon-fiber structure in load-bearing areas (lateral, postero-inferior, inferior) with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. Manufactured from the same plaster mold as the rigid socket to ensure identical internal geometry.
장치: Rigid Socket (RS)
Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed). Standard of care comparator.
활성 비교기: Group 2 (AS -> RS)
Participants receive the Access Socket (AS) first, with 1-2 weeks of adaptation followed by 4 weeks of wear and evaluation. They then switch to the standard rigid socket (RS) for 1-2 weeks of adaptation and 4 weeks of wear, with a second evaluation.
장치: Access Socket (AS)
Hybrid prosthetic socket combining a rigid carbon-fiber structure in load-bearing areas (lateral, postero-inferior, inferior) with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. Manufactured from the same plaster mold as the rigid socket to ensure identical internal geometry.
장치: Rigid Socket (RS)
Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed). Standard of care comparator.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient Specific Functional Scale (PSFS) score
기간: One time at the end of each 4-week wear period (V1, V2 and V3)
Patient-centered self-report tool. The patient identifies 3-5 specific activities they have difficulty performing, then rates their ability on a 0-10 scale (0 = unable to perform, 10 = able to perform at pre-injury level). The final score is the mean of the ratings
One time at the end of each 4-week wear period (V1, V2 and V3)

2차 결과 측정

결과 측정
측정값 설명
기간
Socket Comfort Scale (SCS) score
기간: One time at the end of each 4-week wear period (V1, V2 and V3)
0-10 numerical rating of socket comfort (0 = least comfortable imaginable, 10 = most comfortable imaginable)
One time at the end of each 4-week wear period (V1, V2 and V3)
Orthotics Prosthetics Users Survey (OPUS) score
기간: One time at the end of each 4-week wear period (V1, V2 and V3)
Self-report instrument evaluating functional outcomes and quality of life specifically for orthosis and prosthesis users. Assesses lower-limb functional status, health-related quality of life, satisfaction with the device, and satisfaction with services. The higher the score, the more favorable the result for the device
One time at the end of each 4-week wear period (V1, V2 and V3)
Trinity Amputation and Prosthesis Experience Scale - Revised (TAPES-R) score
기간: One time at the end of each 4-week wear period (V1, V2 and V3)
33-item multidimensional questionnaire evaluating psychosocial adjustment to amputation and prosthesis use, including general adjustment, social adjustment, activity restriction, and prosthesis satisfaction. The higher the global score, the more favorable the result for the device
One time at the end of each 4-week wear period (V1, V2 and V3)
Prosthesis Evaluation Questionnaire - Utility subscale (PEQ-U) score
기간: One time at the end of each 4-week wear period (V1, V2 and V3)
The score is calculated as the mean of the 8 items in the subscale. Each item is rated on a Visual Analogue Scale (VAS) from 0 to 100. The total score ranges from 0 to 100, where higher scores indicate a better outcome (greater satisfaction and prosthesis utility)
One time at the end of each 4-week wear period (V1, V2 and V3)
Proportion of participants electing to keep the Access Socket at study completion
기간: Through study completion, an average of 10 weeks
Percentage of participants who choose the AS over the RS at the end of the study, reported with 95% confidence interval. Participants are not informed of this option until the end of the study to avoid judgment bias
Through study completion, an average of 10 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

협력자

Otto Bock France SNC
Hôpital d'Instruction des armées Percy
Institution Nationale des Invalides
Clinical Investigation Center - University Hospital Grenoble
Hôpital Filieris de Freyming-Merlebach
Ortho Access
H20 Orthopedie

수사관

  • 수석 연구원: Isabelle Loiret, MD, Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 27일

기본 완료 (추정된)

2027년 4월 27일

연구 완료 (추정된)

2027년 10월 30일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 13일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 2026-A00019-42

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

: Individual participant data will not be shared. Aggregated study results will be published in scientific journals and a summary report will be transmitted to the CPP within 12 months of study completion

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다