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

Patellofemoral Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184439
• Other study ID #: PMMHRI-BCO.67/2021-A
• Status: Completed
• Start date: November 25, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2021
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellar Dislocation
• Patellar Instability
• Patellofemoral Osteoarthritis
• Recurrence
• Recurrent Patellar Dislocation

Intervention

Procedure:
• Adductor magnus tenodesis for recurrent patellar dislocation
In all 33 patients (39 knees) adductor magnus tenodesis was performed to stabilise the patella. Adductor magnus tendon was harvested, cut proximally and fixed to the patella with proper tension.

Locations

Country	Name	City	State
Poland	Polish Mother Memorial Hospital Research Institute	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apprehension test	Fear during patellar passive lateralisation	up to six months
Primary	Lysholm Score	Subjective outcome evaluation scale	up to six months
Primary	Kujala Score	Subjective outcome evaluation scale	up to six months
Primary	Sulcus angle	Index describing trochlear shape	up to six months
Primary	Congruence angle	Index describing patellar shift	up to six months
Primary	Patellofemoral angle	Index describing patellar tilt	up to six months
Primary	Caton-Deschamps index	Index describing patellar height	up to six months
Primary	Peak torque	Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)	up to six months
Primary	Torque in 30 deg	Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Newton-Metre (Nm)	up to six months
Primary	Time to peak torque	Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - seconds (s)	up to six months
Primary	Peak torque to body weight	Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Nm/kg	up to six months