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NCT Number: NCT05184439

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.

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Key information

Conditions

Recurrent Patellar Dislocation Joint Diseases Joint Dislocations Knee Injuries Leg Injuries Musculoskeletal Diseases Patellar Dislocation Patellar Instability Patellofemoral Osteoarthritis Wounds and Injuries

Age range

15 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Polish Mother Memorial Hospital Research Institute

Lodz, 93-338, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Apprehension test

    Time frame: up to six months

    Fear during patellar passive lateralisation

  2. Lysholm Score

    Time frame: up to six months

    Subjective outcome evaluation scale

  3. Kujala Score

    Time frame: up to six months

    Subjective outcome evaluation scale

  4. Sulcus angle

    Time frame: up to six months

    Index describing trochlear shape

  5. Congruence angle

    Time frame: up to six months

    Index describing patellar shift

  6. Patellofemoral angle

    Time frame: up to six months

    Index describing patellar tilt

  7. Caton-Deschamps index

    Time frame: up to six months

    Index describing patellar height

  8. Peak torque

    Time frame: 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)

  9. Torque in 30 deg

    Time frame: 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)

  10. Time to peak torque

    Time frame: up to six months

    Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - seconds (s)

  11. Peak torque to body weight

    Time frame: up to six months

    Isokinetic evaluation in speeds 60 and 180 degree per second, both for quadriceps and hamstrings, Units of Measure - Nm/kg

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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