Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier:
NCT00991588
First received: October 6, 2009
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Knee Injuries
Procedure: PCL, posterolateral reconstruction

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Cincinnati Sportsmedicine Research and Education Foundation:

Primary Outcome Measures:
  • Elimination of knee giving-way [ Time Frame: Minimum 2 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete rupture to the posterior cruciate ligament, greater than 10 mm of increased posterior tibial translation
  • Rupture to the posterolateral knee structures, greater than 5 mm of increased lateral tibiofemoral joint opening, greater than 10 degrees of increased external tibial rotation
  • Patient willing to comply with postoperative rehabilitation program

Exclusion Criteria:

  • Patient unwilling to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991588

Locations
United States, Ohio
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Cincinnati Sportsmedicine Research and Education Foundation
Investigators
Principal Investigator: Frank Noyes, M.D. Cincinnati Sportsmedicine Research and Education Foundation
  More Information

No publications provided

Responsible Party: Frank R. Noyes, M.D., President and Medical Director, Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier: NCT00991588     History of Changes
Other Study ID Numbers: PCLPL-001
Study First Received: October 6, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Cincinnati Sportsmedicine Research and Education Foundation:
PCL
Posterolateral

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 21, 2014