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CompletedNCT05184439Updated Oct 5, 2022

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

An observational study in Recurrent Patellar Dislocation, Patellar Instability and Patellofemoral Osteoarthritis, sponsored by Polish Mother Memorial Hospital Research Institute. Completed at 1 site in Poland. Open to participants aged 15 Years to 27 Years. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by Polish Mother Memorial Hospital Research Institute · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
15 Years to 27 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Recurrent Patellar Dislocation
  • Patellar Instability
  • Patellofemoral Osteoarthritis

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Keywords

  • Recurrent Patellar Dislocation
  • Patellar instability
  • Isokinetics
  • Adolescents
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 15 observational studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Polish Mother Memorial Hospital Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 27 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • first-time patellar dislocation
  • habitual patellar dislocation
  • patients with osteochondral fracture
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureAdductor 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.

06

What researchers measure

Primary outcomes

  1. Apprehension test

    Fear during patellar passive lateralisation

    Time frame: up to six months

  2. Lysholm Score

    Subjective outcome evaluation scale

    Time frame: up to six months

  3. Kujala Score

    Subjective outcome evaluation scale

    Time frame: up to six months

  4. Sulcus angle

    Index describing trochlear shape

    Time frame: up to six months

  5. Congruence angle

    Index describing patellar shift

    Time frame: up to six months

  6. Patellofemoral angle

    Index describing patellar tilt

    Time frame: up to six months

  7. Caton-Deschamps index

    Index describing patellar height

    Time frame: up to six months

  8. Peak torque

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

    Time frame: up to six months

  9. 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)

    Time frame: up to six months

  10. Time to peak torque

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

    Time frame: up to six months

  11. 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

    Time frame: up to six months

07

Study locations

1 site
  • Polish Mother Memorial Hospital Research Institute
    Łódź, 93-338, Poland
08

References and documents

Individual participant data

Plan to share: Yes — We will be ready to share our data upon reasonable request of other researchers.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 2022-2030

Access criteria: Upon reasonable request krzynormal@wp.pl

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Sep 2022, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2021
First posted
Jan 11, 2022
StartActual
Nov 25, 2021
Primary completionActual
Sep 1, 2022
CompletionActual
Sep 1, 2022
Last update
Oct 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05184439
Lead sponsor
Polish Mother Memorial Hospital Research Institute
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Nov 25, 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022
Last update
Oct 5, 2022

Study contacts

Krzysztof Małecki, Ph.D.
study director · Polish Mother Memorial Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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