A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction - Full Text View

Sponsors and Collaborators:	Finnish Defense Forces Tampere University Hospital, Department of Musculosceletal Diseases
Information provided by:	Finnish Defense Forces
ClinicalTrials.gov Identifier:	NCT00816647

Purpose

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.

Condition	Intervention
Patella-Dislocation Patellofemoral Osteoarthritis Patellar Instability	Procedure: Patellofemoral stabilizing surgery

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

Resource links provided by NLM:

MedlinePlus related topics: Dislocations Osteoarthritis Surgery

U.S. FDA Resources

Further study details as provided by Finnish Defense Forces:

Primary Outcome Measures:

Recurrent patellar instability [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patellofemoral osteoarthrosis progression. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Medial patellofemoral ligament reconstruction	Procedure: Patellofemoral stabilizing surgery Comparison of surgical techniques
2: Active Comparator Medial reefing	Procedure: Patellofemoral stabilizing surgery Comparison of surgical techniques

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe PF OA
Acute patellar dislocation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816647

Contacts

Contact: Petri J Sillanpaa, M.D., PH.D.

petri.sillanpaa@uta.fi

Locations

Finland
Tampere University Hospital	Recruiting
Tampere, Finland, 33521
Contact: Petri J Sillanpaa petri.sillanpaa@pshp.fi

Sponsors and Collaborators

Finnish Defense Forces

Tampere University Hospital, Department of Musculosceletal Diseases

Investigators

Principal Investigator:

Petri J Sillanpaa, M.D., PhD

Tampere University Hospital, Department of Musculosceletal Diseases

More Information

No publications provided

Responsible Party:	Tampere University Hospital, Department of Musculosceletal Diseases ( Petri Sillanpaa, M.D. )
Study ID Numbers:	MPFL08
Study First Received:	December 31, 2008
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00816647 History of Changes
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by Finnish Defense Forces:

Patella
Dislocation
Knee
Medial Patellofemoral Ligament

Study placed in the following topic categories:

Patellar Dislocation
Musculoskeletal Diseases
Dislocations
Osteoarthritis
Joint Diseases
Arthritis

Wounds and Injuries
Knee Injuries
Disorders of Environmental Origin
Leg Injuries
Rheumatic Diseases

Additional relevant MeSH terms:

Patellar Dislocation
Musculoskeletal Diseases
Osteoarthritis
Dislocations
Joint Diseases
Arthritis

Wounds and Injuries
Knee Injuries
Disorders of Environmental Origin
Leg Injuries
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 02, 2009