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

Patellofemoral Osteoarthritis Clinical Trial

Official title:

A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816647
• Other study ID #: MPFL08
• Status: Terminated
• Phase: N/A
• First received: December 31, 2008
• Last updated: June 13, 2011
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2009
• Source: Finnish Defense Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Chronic patellar instability (more than 2 dislocations)

• Minimum 6 months nonoperative treatment

Exclusion Criteria:

• Severe PF OA

• Acute patellar dislocation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Patella-Dislocation
• Patellar Dislocation
• Patellar Instability
• Patellofemoral Osteoarthritis

Intervention

Procedure:
• Patellofemoral stabilizing surgery
Comparison of surgical techniques

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Finnish Defense Forces	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent patellar instability		2 years	No
Secondary	Patellofemoral osteoarthrosis progression.		2 years	No