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

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

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 Overview

• Status: Completed
• Conditions: Patellofemoral Osteoarthritis; Recurrent Patellar Dislocation; Patellar Instability
• Intervention / Treatment: Procedure: Adductor magnus tenodesis for recurrent patellar dislocation

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 93-338
    • Polish Mother Memorial Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 27 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group after surgery; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apprehension test	Fear during patellar passive lateralisation	up to six months
Lysholm Score	Subjective outcome evaluation scale	up to six months
Kujala Score	Subjective outcome evaluation scale	up to six months
Sulcus angle	Index describing trochlear shape	up to six months
Congruence angle	Index describing patellar shift	up to six months
Patellofemoral angle	Index describing patellar tilt	up to six months
Caton-Deschamps index	Index describing patellar height	up to six months
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
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
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
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

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Recurrent Patellar Dislocation; Patellar instability; Isokinetics
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Recurrence; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: PMMHRI-BCO.67/2021-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will be ready to share our data upon reasonable request of other researchers.
• IPD Sharing Time Frame: 2022-2030
• IPD Sharing Access Criteria: Upon reasonable request krzynormal@wp.pl
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No