Volar Locking Plate로 치료한 원위 요골 골절 후 즉각적인 가동화 대 2주 깁스 고정화 (LIMPER-DRF)
Volar Locking Plate로 치료한 원위 요골 골절 후 즉시 가동화 대 2주 깁스 고정화 - 전향적, 무작위, 통제 시험을 위한 연구 프로토콜
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
연구 개요
상태
정황
상세 설명
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Exclusion Criteria:
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
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 |
|---|---|
|
실험적: 손바닥 잠금판으로 치료한 원위 요골 골절 후 즉시 동원
|
Immediate mobilization postoperatively without casting Volar plating of distal radius fracture |
|
활성 비교기: 손바닥 잠금판으로 치료한 원위 요골 골절 후 2주간 깁스 고정
|
Volar plating of distal radius fracture Dorsal cast placed in OR |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
기간: 2 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
2 months
|
|
Total lenght of the sick leave
기간: 12 months
|
Total number of days of work during the 1 year study period |
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
기간: 4 weeks
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
4 weeks
|
|
Patient-rated wrist evaluation questionnaire
기간: 6 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
6 months
|
|
Patient-rated wrist evaluation questionnaire
기간: 12 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
12 months
|
|
Return to work
기간: 4 weeks
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
4 weeks
|
|
Return to work
기간: 2 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
2 months
|
|
Return to work
기간: 6 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
6 months
|
|
Return to work
기간: 12 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
12 months
|
|
Complications
기간: 4 weeks
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
4 weeks
|
|
Complications
기간: 2 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
2 months
|
|
Complications
기간: 6 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
6 months
|
|
Complications
기간: 12 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
12 months
|
|
Self-perceived working ability
기간: 4 weeks
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
4 weeks
|
|
Self-perceived working ability
기간: 2 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
2 months
|
|
Self-perceived working ability
기간: 6 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
6 months
|
|
Self-perceived working ability
기간: 12 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
12 months
|
|
Visual analogue pain scale
기간: 4 weeks
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
4 weeks
|
|
Visual analogue pain scale
기간: 2 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
2 months
|
|
Visual analogue pain scale
기간: 6 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
6 months
|
|
Visual analogue pain scale
기간: 12 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
12 months
|
|
Patient-acceptable symptom state
기간: 2 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
2 months
|
|
Patient-acceptable symptom state
기간: 6 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
6 months
|
|
Patient-acceptable symptom state
기간: 12 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
12 months
|
|
Work capacity
기간: 4 weeks
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
4 weeks
|
|
Work capacity
기간: 2 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
2 months
|
|
Work capacity
기간: 6 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
6 months
|
|
Work capacity
기간: 12 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient activity
기간: 4 weeks
|
Patient activity measured with triaxial wrist accelerometer |
4 weeks
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Aleksi Reito, Tampere University Hospital
- 수석 연구원: Laura Kärnä, MD, Tampere University Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data is available on reasonable request.
IPD 공유 기간
After the study has been completed and for 10 years after.
IPD 공유 액세스 기준
On reasonable request and research plan for IPD use should be provided.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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