Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991588
Recruitment Status : Enrolling by invitation
First Posted : October 8, 2009
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation

Brief Summary:
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 or disease Intervention/treatment
Knee Injuries Procedure: PCL, posterolateral reconstruction

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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee
Study Start Date : October 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Elimination of knee giving-way [ Time Frame: Minimum 2 years postoperatively ]

Secondary Outcome Measures :
  1. Posterior tibial translation [ Time Frame: Minimum 2 years postoperative ]
  2. Lateral tibiofemoral joint opening [ Time Frame: Minimum 2 years postoperatively ]
  3. External tibial rotation [ Time Frame: Minimum 2 years postoperatively ]
  4. Elimination of knee pain [ Time Frame: Minimum 2 years postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for PCL and/or posterolateral reconstruction

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991588

United States, Ohio
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, United States, 45242
Sponsors and Collaborators
Sue Barber-Westin
Principal Investigator: Frank Noyes, M.D. Cincinnati Sportsmedicine Research and Education Foundation

Responsible Party: Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation Identifier: NCT00991588     History of Changes
Other Study ID Numbers: PCLPL-001
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation:

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