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Clinical Trials/NCT05706363
NCT05706363
Active, Not Recruiting
N/A

Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.

Aarhus University Hospital1 site in 1 country90 target enrollmentJuly 1, 2017
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ConditionsPatellar Dislocation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patellar Dislocation
Sponsor
Aarhus University Hospital
Enrollment
90
Locations
1
Primary Endpoint
Kujala (Anterior Knee Pain Scale)
Status
Active, Not Recruiting
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.

It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
July 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Martin Lind

Professor

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
  • •The growth zones must be found closed - verified by MRI scan

Exclusion Criteria

  • •Patients with known rheumatoid arthritis.
  • •Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
  • •Inability to follow a normal rehabilitation regime.
  • •Previous ligament surgery in injured knees.

Outcomes

Primary Outcomes

Kujala (Anterior Knee Pain Scale)

Time Frame: 24 month

Patient reported outcome score, 0=worst and 100=best

Secondary Outcomes

  • Knee injury and Osteoarthritis Outcome Score (KOOS)(24 month)
  • Donor site morbidity score, 0=worst and 100=best(24 month)
  • Lysholm-Tegner (Activity Score)(24 month)
  • Numerical Rating Scale (NRS-pain score)(24 month)
  • Knee pain(24 month)
  • Patella Re-luxation sensation(24 month)

Study Sites (1)

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