Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: A Randomized Controlled Trial
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.
調査の概要
詳細な説明
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- non-weightbearing
- partial weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
- Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kayla Seiffert
- 電話番号：952-456-7085
- メール：research@tcomn.com
研究連絡先のバックアップ
- 名前：Becky McGaver
- 電話番号：952-456-7136
- メール：research@tcomn.com
研究場所
-
-
Minnesota
-
Edina、Minnesota、アメリカ、55435
- 募集
- Twin Cities Orthopedics
-
コンタクト：
- Becky Stone
- 電話番号：952-456-7136
- メール：research@tcomn.com
-
主任研究者：
- Robert F LaPrade, MD, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ≥ 14 years old, <60
- Reconstruction of PCL alone
- Reconstruction of MCL alone
- Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
- Reconstruction of multiligament injuries (ACL+MCL)
- Males or females
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion Criteria:
- < 14 years old
- >60 years old
- Pregnant
- Revision PCL reconstructions
- Previous or concurrent vascular injury (vascular bypass procedure)
- Associated fractures requiring concurrent surgery
- Concurrent meniscal root or radial repair surgery
研究計画
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：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Non-weightbearing for the first six weeks after surgery
Not weightbearing after surgery |
Patient is randomized to the weightbearing group the day after surgery. |
|
実験的：Partial weight -bearing for the first six weeks after surgery
Partial weightbearing will be defined as 40% of the patient's body weight. |
Patient is randomized to the weightbearing group the day after surgery. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
時間枠：Pre-operative
|
stress radiographs |
Pre-operative
|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
時間枠：6 months post-surgery
|
stress radiographs |
6 months post-surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numeric Pain Scale (NPS) (0-10 rating)
時間枠：Baseline and 6 months
|
Pain scale 0-100 |
Baseline and 6 months
|
|
Measurements by physical therapists (Edema, thigh circumference)
時間枠：4,7, and 10 months after surgery
|
Measurements with tape |
4,7, and 10 months after surgery
|
|
Measurements by physical therapists (Quadriceps strength, gait analysis)
時間枠：4,7, and 10 months after surgery
|
Measurements by biomechanics lab |
4,7, and 10 months after surgery
|
|
Patient reported outcome scores
時間枠：Baseline, 3 months, 6 months, 1 year
|
Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction |
Baseline, 3 months, 6 months, 1 year
|
|
Measurements by physical therapists (range of motion)
時間枠：4,7, and 10 months after surgery
|
Measurements with goniometer |
4,7, and 10 months after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Robert F LaPrade, MD, PhD、Twin Cities Orthopedics
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RFL_NWB vs PWB-Multi-Knee Lig
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。