Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction

NCT00991588 | Completed DMC

• 1 other identifier: PCLPL-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries

Keywords

PCL; Posterolateral

Outcome Measures

Primary Outcomes (1)

• Elimination of knee giving-way

  Minimum 2 years postoperatively

Secondary Outcomes (4)

• 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

Study Arms (1)

PCL, posterolateral reconstruction

All patients who are entered into study who receive a PCL and/or posterolateral knee ligament reconstruction

Procedure: PCL, posterolateral reconstruction

Interventions

PCL, posterolateral reconstruction PROCEDURE

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.

PCL, posterolateral reconstruction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for PCL and/or posterolateral reconstruction

You may qualify if:

• 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

You may not qualify if:

• Patient unwilling to participate

Sponsors & Collaborators

• Sue Barber-Westin: lead

Study Sites (1)

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Frank Noyes, M.D.

  Cincinnati Sportsmedicine Research and Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Clinical Studies

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 8, 2009
• Study Start: October 1, 2009
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)