Clinical trial NCT05184439: Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Official title: Clinical, Radiological and Isokinetic Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Patellar Dislocation
Patellar Instability
Patellofemoral Osteoarthritis
Keywords: Recurrent Patellar Dislocation
Patellar instability
Isokinetics
Adolescents
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 22
Sex: ALL
Minimum age (years): 15
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of 33 patients (39 knees operated) after abductor magnus tenodesis for recurrent patellar dislocation with age under 18 at the time of surgery. With follow-up at least 10 years, present age of the subjects between 15 and 27 years.

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.

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

Primary outcomes:
measure: Apprehension test
timeFrame: up to six months
measure: Lysholm Score
timeFrame: up to six months
measure: Kujala Score
timeFrame: up to six months
measure: Sulcus angle
timeFrame: up to six months
measure: Congruence angle
timeFrame: up to six months
measure: Patellofemoral angle
timeFrame: up to six months
measure: Caton-Deschamps index
timeFrame: up to six months
measure: Peak torque
timeFrame: up to six months
measure: Torque in 30 deg
timeFrame: up to six months
measure: Time to peak torque
timeFrame: up to six months
measure: Peak torque to body weight
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Polish Mother Memorial Hospital Research Institute
Study officials:
affiliation: Polish Mother Memorial Hospital Research Institute
name: Krzysztof Małecki, Ph.D.
role: STUDY_DIRECTOR
References: