Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction
The purpose of this investigation is to determine the clinical outcome of surgical reconstruction of complete ruptures to the posterior cruciate ligament (PCL) and posterolateral structures of the knee joint. The outcome will be determined with validated and rigorous knee rating systems between 2 and 10 years postoperatively. The results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation. We hypothesize that the appropriately indicated procedures will effectively restore normal knee stability and function in patients with isolated or combined injuries to these structures.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee|
- Elimination of knee giving-way [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]
- Posterior tibial translation [ Time Frame: Minimum 2 years postoperative ] [ Designated as safety issue: No ]
- Lateral tibiofemoral joint opening [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]
- External tibial rotation [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]
- Elimination of knee pain [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: PCL, posterolateral reconstruction
All patients who are entered into study who receive a PCL and/or posterolateral knee ligament reconstruction
Procedure: PCL, posterolateral reconstruction
The operative procedures involve either a single- or double-strand PCL graft which is usually harvested from the patient's knee. In cases of multiple ligament procedures, allograft tissues may be used which are obtained from tissue banks certified by the American Associate of Tissue Banks and that have passed FDA inspection. The posterolateral structures, including the fibular collateral ligament (FCL), are reconstructed with one or two grafts, depending upon the severity of damage encountered at surgery.
Because injuries to the PCL and posterolateral structures occur with less frequency than other structures in the knee joint (such as the anterior cruciate ligament and menisci), fewer studies are available to assist the surgeon and patient with appropriate decision-making regarding conservative versus surgical treatment. The majority of patients who sustain injury to these structures are treated conservatively. Unfortunately, several investigations describe noteworthy symptoms and functional limitations following conservative management, and a high percentage of patients develop knee osteoarthritis that can be disabling for both recreational and daily activities. The investigators of this study have nearly three decades of experience and have extensively studied the effects of this injury in both the laboratory and clinic settings. It is our opinion that surgical reconstruction provides significant benefit when appropriately indicated, as has been demonstrated in our previous studies. Especially in athletic individuals, PCL and posterolateral reconstructive procedures have advanced to the point where more predictable results can be expected to restore sufficient knee function. Studies have demonstrated, at least in the short-term, that the majority of patients with acute ligament ruptures treated with reconstruction are able to return to various levels of sports activities.12 Whether these procedures will decrease the risk of the patient developing future osteoarthritis is unknown and requires further study.
|United States, Ohio|
|Cincinnati Sportsmedicine and Orthopaedic Center|
|Cincinnati, Ohio, United States, 45242|
|Principal Investigator:||Frank Noyes, M.D.||Cincinnati Sportsmedicine Research and Education Foundation|