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

NCT05184439 | Completed

• 1 other identifier: PMMHRI-BCO.67/2021-A
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Patellar Dislocation; Patellar Instability; Patellofemoral Osteoarthritis

Keywords

Recurrent Patellar Dislocation; Patellar instability; Isokinetics; Adolescents

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

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

Interventions

Adductor magnus tenodesis for recurrent patellar dislocation PROCEDURE

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.

Study group after surgery

Eligibility Criteria

• Age: 15 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

Polish Mother Memorial Hospital Research Institute

Lodz, 93-338, Poland

Location

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Officials

• Krzysztof Małecki, Ph.D.

  Polish Mother Memorial Hospital Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 11, 2022
• Study Start: November 25, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 5, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2022-2030
• Access Criteria: Upon reasonable request krzynormal@wp.pl

Locations

PL (1)