Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics

January 10, 2019 updated by: Martin Lind, Aarhus University Hospital
The purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Division of Sports Trauma, Tage-Hansens Gade 2b

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patella luxation, more than 2 times

Exclusion Criteria:

  • cartilage damage (grad 3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anchor fixation
Medial fixation of the reconstruction at the medial femural condyle with suture anchors.
Other: Anchor fixation
Other: Screw fixation
Medial fixation of the reconstruction at the medial femural condyle with a screw.
Other: Anchor fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of subjective symptoms with a patient reported outcome score
Time Frame: Baseline, 6 months 12 Months, 24 months
Anterior Knee Pain Scale
Baseline, 6 months 12 Months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome scores
Time Frame: Baseline, 6 months 12 Months, 24 months
Tegner
Baseline, 6 months 12 Months, 24 months
Patient reported outcome scores
Time Frame: Baseline, 6 months 12 Months, 24 months
KOOS (Knee injury and osteoarthritis outcome score)
Baseline, 6 months 12 Months, 24 months
Re-operation rate
Time Frame: Baseline, 6 months 12 Months, 24 months
Baseline, 6 months 12 Months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish EC 1-10-72-194-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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