Clinical trial NCT00991588: Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction
Official title: Reconstruction of the Posterior Cruciate Ligament and Posterolateral Structures of the Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Keywords: PCL
Posterolateral
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for PCL and/or posterolateral reconstruction

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elimination of knee giving-way
timeFrame: Minimum 2 years postoperatively
Secondary outcomes:
measure: Posterior tibial translation
timeFrame: Minimum 2 years postoperative
measure: Lateral tibiofemoral joint opening
timeFrame: Minimum 2 years postoperatively
measure: External tibial rotation
timeFrame: Minimum 2 years postoperatively
measure: Elimination of knee pain
timeFrame: Minimum 2 years postoperatively
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Sportsmedicine and Orthopaedic Center
state: Ohio
Study officials:
affiliation: Cincinnati Sportsmedicine Research and Education Foundation
name: Frank Noyes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: