A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction

NCT ID: NCT00816647

Last Updated: 2011-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-06-30

Brief Summary

The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

Detailed Description

Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

Conditions

Patella-Dislocation; Patellofemoral Osteoarthritis; Patellar Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Medial patellofemoral ligament reconstruction

Group Type: ACTIVE_COMPARATOR

Patellofemoral stabilizing surgery

Intervention Type: PROCEDURE

Comparison of surgical techniques

2

Medial reefing

Group Type: ACTIVE_COMPARATOR

Patellofemoral stabilizing surgery

Intervention Type: PROCEDURE

Comparison of surgical techniques

Interventions

Patellofemoral stabilizing surgery

Comparison of surgical techniques

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chronic patellar instability (more than 2 dislocations)
• Minimum 6 months nonoperative treatment

Exclusion Criteria

• Severe PF OA
• Acute patellar dislocation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Finnish Defense Forces

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tampere University Hospital, Department of Musculosceletal Diseases

Principal Investigators

Petri J Sillanpaa, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

MPFL08

Identifier Type: -

Identifier Source: org_study_id