Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee

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 Overview

• Status: Completed
• Conditions: Knee Injuries
• Intervention / Treatment: 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
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Sportsmedicine and Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for PCL and/or posterolateral reconstruction

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Elimination of knee giving-way	Minimum 2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Posterior tibial translation	Minimum 2 years postoperative
Lateral tibiofemoral joint opening	Minimum 2 years postoperatively
External tibial rotation	Minimum 2 years postoperatively
Elimination of knee pain	Minimum 2 years postoperatively

Collaborators and Investigators

• Sponsor: Sue Barber-Westin
• Investigators: Principal Investigator: Frank Noyes, M.D., Cincinnati Sportsmedicine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Posterolateral; PCL
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: PCLPL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes