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Clinical Trials/NCT05184439
NCT05184439
Completed
Not Applicable

Clinical, Radiological and Isokinetic Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.

Polish Mother Memorial Hospital Research Institute1 site in 1 country22 target enrollmentNovember 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent Patellar Dislocation
Sponsor
Polish Mother Memorial Hospital Research Institute
Enrollment
22
Locations
1
Primary Endpoint
Apprehension test
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Between 2010 and 2012, 33 children and adolescents (39 knees) with recurrent patellar dislocation were treated with MPFL reconstruction using the adductor magnus tendon.The aim of the study is to assess the effectiveness of this surgical procedure in long follow-up. The outcomes will be evaluated functionally (Lysholm knee scale, the Kujala Anterior Knee Pain Scale, and isokinetic examination) and radiographically (Caton-Deschamps index, sulcus angle, congruence angle, and patellofemoral angle). This is a continuation of the research published in 2015 with longer follow-up at least 10 years. All available patients will be evaluated with the same protocol, using the same methods and devices. Functional outcome is planned to be measured with scales as above. In radiological assessment Merchant and lateral knee weight bearing view and additionally MRI will be performed. Isokinetic test will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured and compared to those from former research. Dedicated statistical test will be used for both: analysis of present status and differences from former results.

Detailed Description

Recurrent dislocation of the patella is a common orthopaedic problem which occurs in about 44% of cases after first-time dislocation. In most cases of first-time patellar dislocation, the medial patellofemoral ligament (MPFL) becomes damaged. Between 2010 and 2012, 33 children and adolescents (39 knees) with recurrent patellar dislocation were treated with MPFL reconstruction using the adductor magnus tendon. The aim of the study is to assess the effectiveness of this surgical procedure in long follow-up. The outcomes will be evaluated functionally (Lysholm knee scale, the Kujala Anterior Knee Pain Scale, and isokinetic examination) and radiographically (Caton-Deschamps index, sulcus angle, congruence angle, and patellofemoral angle). This is a continuation of the research published in 2015 with longer follow-up at least 10 years. All available patients will be evaluated with the same protocol, using the same methods and devices. Functional outcome is planned to be measured with scales as above. In radiological assessment Merchant and lateral knee weight bearing view and additionally MRI will be performed. Isokinetic test will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured and compared to those from former research. Dedicated statistical test will be used for both: analysis of present status and differences from former results.

Registry
clinicaltrials.gov
Start Date
November 25, 2021
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Polish Mother Memorial Hospital Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patellar dislocation that had occurred at least twice,
  • positive apprehensive test,
  • completed research protocol
  • age under 18 years at the time of surgery (adductor magnus tenodesis according to Avikainen)

Exclusion Criteria

  • first-time patellar dislocation
  • habitual patellar dislocation
  • patients with osteochondral fracture

Outcomes

Primary Outcomes

Apprehension test

Time Frame: up to six months

Fear during patellar passive lateralisation

Lysholm Score

Time Frame: up to six months

Subjective outcome evaluation scale

Kujala Score

Time Frame: up to six months

Subjective outcome evaluation scale

Sulcus angle

Time Frame: up to six months

Index describing trochlear shape

Congruence angle

Time Frame: up to six months

Index describing patellar shift

Patellofemoral angle

Time Frame: up to six months

Index describing patellar tilt

Caton-Deschamps index

Time Frame: up to six months

Index describing patellar height

Peak torque

Time Frame: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)

Torque in 30 deg

Time Frame: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)

Time to peak torque

Time Frame: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - seconds (s)

Peak torque to body weight

Time Frame: up to six months

Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Nm/kg

Study Sites (1)

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