- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00816998
Range of Motion and Patients With Distal Radius Fractures
The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures
Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization.
Specific Aim:
To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The following criteria must be met to be enrolled:
- Have a closed unstable distal radius fracture
- Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture
- Be a male or non-pregnant female at least 18 years of age.
- Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- Have the ability to understand and provide written authorization for use and disclosure of personal health information
Exclusion Criteria:
Participants are excluded if they:
Have any of the following conditions
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open, multi-fragmentary fracture
- Artery or Nerve injury secondary to fracture
- Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment
- Are currently on chemotherapy or radiation therapy
- A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- A history of uncontrolled diabetes
- Are unable to provide consent for the study
- Are unable to make the follow-up appointments required of the study
공부 계획
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: Early
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
|
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
|
|
다른: Delayed
Participants randomized to this group will begin physical therapy of their fractured wrist approximately 6 weeks from their surgery.
This is the approximate time frame in which therapy begins for patients not involved in the study.
The term Delayed refers to therapy being delayed in starting from those in the study who begin therapy at one week post-operatively, not a delay in current care practice.
|
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Range of motion measurements
기간: at each study visit
|
at each study visit
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Pinch strength
기간: at each study visit
|
at each study visit
|
|
Grip strength
기간: at each study visit
|
at each study visit
|
|
Pain
기간: at each study visit
|
at each study visit
|
|
Return to work
기간: at each study visit
|
at each study visit
|
|
Scores of DASH & PRWE questionnaires
기간: at each study visit
|
at each study visit
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .