Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991588
• Other study ID #: PCLPL-001
• Status: Completed
• Start date: October 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Cincinnati Sportsmedicine Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sue Barber-Westin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination of knee giving-way		Minimum 2 years postoperatively
Secondary	Posterior tibial translation		Minimum 2 years postoperative
Secondary	Lateral tibiofemoral joint opening		Minimum 2 years postoperatively
Secondary	External tibial rotation		Minimum 2 years postoperatively
Secondary	Elimination of knee pain		Minimum 2 years postoperatively