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Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation Identifier:
First received: October 6, 2009
Last updated: January 30, 2017
Last verified: January 2017
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: Observational [Patient Registry]
Study Design: 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

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 ]

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

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Ages Eligible for Study:   Child, Adult, Senior
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
  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 identifier: 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
  More Information

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
Study First Received: October 6, 2009
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Cincinnati Sportsmedicine Research and Education Foundation:

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries processed this record on April 24, 2017