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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

2021년 9월 20일 업데이트: Ryan McMillen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

연구 유형

중재적

등록 (실제)

5

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Pennsylvania
      • Clairton, Pennsylvania, 미국, 15025
        • Steel Valley Orthopaedic and Sports Medicine
      • Pittsburgh, Pennsylvania, 미국, 15224
        • The Foot & Ankle Institute/Western Pennsylvania Hospital

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Males or females age 18 to 89 years
  2. Undergoing foot and ankle surgery
  3. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

  1. Diagnosed peripheral neuropathy
  2. Diagnosed peripheral vascular disease
  3. Documented infection to the surgical extremity
  4. Previous surgery to the surgical limb
  5. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
  6. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

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: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Immediate protected weight-bearing
다른: Weight Bearing
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
다른 이름들:
  • 조기 체중 부하
다른: Traditional non weight bearing
Strict non-weight-bearing
다른: Strict non-weight bearing
Strict non weight bearing for 6 weeks following foot & ankle surgery
다른 이름들:
  • Non-weight bearing

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
기간: Both Arms: Screening
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Screening
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
기간: Both Arms: Post-operative 6-8 weeks
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 6-8 weeks
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
기간: Both Arms: Post-operative 3 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 3 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
기간: Both Arms: Post-operative 12 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 12 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
기간: Both Arms: Post-operative 24 month
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy
Both Arms: Post-operative 24 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
기간: Both Arms: Screening
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Screening
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
기간: Both Arms: Post-operative 6-8 weeks
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 6-8 weeks
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
기간: Both Arms: Post-operative 3 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 3 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
기간: Both Arms: Post-operative 12 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 12 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
기간: Both Arms: Post-operative 24 month
36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy
Both Arms: Post-operative 24 month

2차 결과 측정

결과 측정
측정값 설명
기간
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Screening
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 2-3 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6-8 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 3 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 6 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 12 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 24 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
Both arms: Post-operative 24 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Screening
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Screening
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 2-3 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 2-3 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 6-8 weeks
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6-8 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 3 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 3 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 6 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 6 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 12 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 12 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
기간: Both arms: Post-operative 24 month
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
Both arms: Post-operative 24 month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

수사관

  • 수석 연구원: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine

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)

2019년 7월 29일

기본 완료 (실제)

2021년 7월 15일

연구 완료 (실제)

2021년 7월 15일

연구 등록 날짜

최초 제출

2019년 5월 22일

QC 기준을 충족하는 최초 제출

2019년 6월 21일

처음 게시됨 (실제)

2019년 6월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 9월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 9월 20일

마지막으로 확인됨

2021년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 2019-124JH

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion. No other outside entities are involved in this research study.

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. .

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