Recurrent Patellar DislocationNCT05184439
Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
An observational study of Recurrent Patellar Dislocation and Patellar Instability, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 15 to 27 years
- Conditions the study is for
- Recurrent Patellar Dislocation, Patellar Instability, Patellofemoral Osteoarthritis
- What is being tested?
- Adductor magnus tenodesis for recurrent patellar dislocation
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 25 Nov 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- first-time patellar dislocation
- habitual patellar dislocation
- patients with osteochondral fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Adductor magnus tenodesis for recurrent patellar dislocation
- Keywords
- Recurrent Patellar Dislocation, Patellar instability, Isokinetics, Adolescents
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor magnus tenodesis for recurrent patellar dislocationProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Adductor magnus tenodesis for recurrent patellar dislocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apprehension test
Fear during patellar passive lateralisation
Measured: up to six months
Lysholm Score
Subjective outcome evaluation scale
Measured: up to six months
Kujala Score
Subjective outcome evaluation scale
Measured: up to six months
Sulcus angle
Index describing trochlear shape
Measured: up to six months
Congruence angle
Index describing patellar shift
Measured: up to six months
Patellofemoral angle
Index describing patellar tilt
Measured: up to six months
Caton-Deschamps index
Index describing patellar height
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Nov 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Patellar DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Małecki, Ph.D., Study director, Polish Mother Memorial Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184439
- Sponsor's protocol ID
- PMMHRI-BCO.67/2021-A
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will be ready to share our data upon reasonable request of other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological and Isokinetic Evaluation of Adductor Magnus Tenodesis in Patients With Recurrent Patellar Dislocation.
- ClinicalTrials.gov ID
- NCT05184439
- Acronym / sponsor ID
- PMMHRI-BCO.67/2021-A
- Keywords
- Recurrent Patellar Dislocation, Patellar instability, Isokinetics, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group after surgery | – | Procedure: Adductor magnus tenodesis for recurrent patellar dislocation33 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. |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- first-time patellar dislocation
- habitual patellar dislocation
- patients with osteochondral fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adductor magnus tenodesis for recurrent patellar dislocationIn 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. | Procedure or surgery | Study group after surgery |
Primary outcome
Apprehension test
Time frame: up to six months
Fear during patellar passive lateralisation
Lysholm Score
Time frame: up to six months
Subjective outcome evaluation scale
Kujala Score
Time frame: up to six months
Subjective outcome evaluation scale
Sulcus angle
Time frame: up to six months
Index describing trochlear shape
Congruence angle
Time frame: up to six months
Index describing patellar shift
Patellofemoral angle
Time frame: up to six months
Index describing patellar tilt
Caton-Deschamps index
Time frame: up to six months
Index describing patellar height
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)
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)
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: Yes. We will be ready to share our data upon reasonable request of other researchers.
Related trials for Recurrent Patellar Dislocation
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Recruiting
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Patellar Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Małecki, Ph.D. study director
Polish Mother Memorial Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Patellar Dislocation and Patellar Instability, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apprehension test (time frame: up to six months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.