Range of Motion and Patients With Distal Radius Fractures
2011年4月6日 更新者：Mayo Clinic
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.
調査の概要
詳細な説明
You are scheduled for surgery of your broken wrist.
Treatment of broken bones of the wrist, such as distal radius fractures, may require different types of treatment.
For this study this type of fracture will be treated by surgery to place a plate with screws to the broken bone and then a plaster splint will be applied.
After surgery, physical therapy will be started.
Following surgery you will be assigned to one of four groups by the type of wrist fracture (broken bone) you have.
Each person will by chance (the flip of a coin) be put in either the Early or Delayed Range of Motion groups.
Those in the Early Range of Motion groups will begin exercises for motion starting 7 days after surgery.
Those in the Delayed Range of Motion, will begin exercises for motion starting about five weeks after surgery.
Once you begin the exercises to help you get back normal use of your wrist, you will have measurements of how much motion and strength you have in the wrist and hand that was fractured.
The measurements will take about five minutes to complete.
All participants will have an x-ray of the wrist at 2, & 6 weeks following surgery and if needed at other appointments.
At each appointment you will be asked to fill out four questionnaires, asking about pain and how you are getting along with the broken bone in your wrist.
The questionnaires will take about 20 minutes of your time to complete.
At Week 26 you will be asked to record the amount of motion you have in both of your wrists on paper drawings as well as the measurements that we will make.
Working with the drawings will take approximately five minutes.
At Week 52 you will be asked two questions about how satisfied you are with the results of your surgery.
Surgery, x-ray of your wrist, and exercise to help you get back motion of your broken wrist are all standard orthopedic practice for treating a broken wrist bone.
研究の種類
介入
入学 (実際)
39
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Range of motion measurements
時間枠：at each study visit
|
at each study visit
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Pinch strength
時間枠：at each study visit
|
at each study visit
|
|
Grip strength
時間枠：at each study visit
|
at each study visit
|
|
Pain
時間枠：at each study visit
|
at each study visit
|
|
Return to work
時間枠：at each study visit
|
at each study visit
|
|
Scores of DASH & PRWE questionnaires
時間枠：at each study visit
|
at each study visit
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2006年10月1日
一次修了 (実際)
2010年2月1日
研究の完了 (実際)
2010年2月1日
試験登録日
最初に提出
2009年1月5日
QC基準を満たした最初の提出物
2009年1月5日
最初の投稿 (見積もり)
2009年1月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年4月8日
QC基準を満たした最後の更新が送信されました
2011年4月6日
最終確認日
2011年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Physical therapyの臨床試験
-
University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
-
Centre Hospitalier Universitaire de Besancon募集
-
Saglik Bilimleri UniversitesiMedical Park Hospital Istanbul完了
-
Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
-
Universitätsklinikum Hamburg-Eppendorf完了