Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.

Completed

• Conditions: Patellar Instability; Patellofemoral Osteoarthritis; Recurrent Patellar Dislocation
• Interventions: Procedure: Adductor magnus tenodesis for recurrent patellar dislocation

• Registration Number: NCT05184439
• Lead Sponsor: Polish Mother Memorial Hospital Research Institute

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-25
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group after surgery	Adductor magnus tenodesis for recurrent patellar dislocation	33 children and adolescents (39 knees) with recurrent patellar dislocation were treated with MPFL reconstruction using the adductor magnus tendon between 2010 and 2012. The group is under clinical observation with evaluation being made.

Primary Outcome Measures

Name	Time	Method
Apprehension test	up to six months	Fear during patellar passive lateralisation
Lysholm Score	up to six months	Subjective outcome evaluation scale
Kujala Score	up to six months	Subjective outcome evaluation scale
Sulcus angle	up to six months	Index describing trochlear shape
Congruence angle	up to six months	Index describing patellar shift
Patellofemoral angle	up to six months	Index describing patellar tilt
Caton-Deschamps index	up to six months	Index describing patellar height
Peak torque	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	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	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	up to six months	Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Nm/kg

Trial Locations

Locations (1)

Polish Mother Memorial Hospital Research Institute; 🇵🇱 Łódź, Poland