Recurrent Patellar DislocationNCT03983213
The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent 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
The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Patellar Dislocation, Patellar Instability
- What is being tested?
- mpfl reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 sitePoland
- Study dates
- 28 May 2019to 30 Nov 2020
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 45 patients under 18 yo, 30 females, 15 males, average age of 15 yo
Who may be able to join
- age <18 yo
- recurrent patellar dislocation
- ready for follow-up
Who cannot join
- age <18 yo
- osteochondral fracture
- habitual dislocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.
The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction. Follow-up longer than 2 years in all cases, about 45 patients included.
Read the detailed description
Recurrent patellar dislocation occurs mostly in adolescents. Recently medial patellofemoral ligament reconstruction has become treatment of choice in most cases. There is still insufficient literature to assess the operative treatment results according to functional testing.
The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction with gracilis tendon harvesting. Follow-up provided is longer than 2 years in all 45 cases planned to enroll. All subject are to be mailed and invited to check-up visit including analysis of parameters mentioned above. Soon after data collection text of the publication will be made. The results will be discussed with recent literature and conclusions will be made.
- Being tested
- mpfl reconstruction
- Keywords
- Patellar instability, Recurrent patellar dislocation, Isokinetics, Children, MPFL reconstruction
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpfl reconstructionProcedure or surgery
Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.
| Study group | Role | What they receive |
|---|---|---|
| Pat. after mpfl reconstruction | All 45 subjects operated with mpfl reconstruction included to chek-up after follow-up. Receives: Procedure: mpfl reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation recurrence
The incident of patellar dislocation after treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start28 May 2019
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
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-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kryspin Niedzielski, Ph.D., Study chair, Polish Mother Memorial Hospital Research InstituteKrzysztof Małecki, Ph.D., Study director, Polish Mother Memorial Hospital Research InstituteJacek Beczkowski, M.D., Principal investigator, Polish Mother Memorial Hospital Research InstitutePaweł Flont, Ph. D., Principal investigator, Polish Mother Memorial Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983213
- Sponsor's protocol ID
- PMMHRI-BCO.34/2019
- Status last verified
- Sep 2020
- First submitted
- 10 Jun 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing IPD after data collection in Exel
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.
- ClinicalTrials.gov ID
- NCT03983213
- Acronym / sponsor ID
- PMMHRI-BCO.34/2019
- Keywords
- Patellar instability, Recurrent patellar dislocation, Isokinetics, Children, MPFL reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 12 Jun 2019 (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.
The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction. Follow-up longer than 2 years in all cases, about 45 patients included.
Detailed description
Recurrent patellar dislocation occurs mostly in adolescents. Recently medial patellofemoral ligament reconstruction has become treatment of choice in most cases. There is still insufficient literature to assess the operative treatment results according to functional testing.
The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction with gracilis tendon harvesting. Follow-up provided is longer than 2 years in all 45 cases planned to enroll. All subject are to be mailed and invited to check-up visit including analysis of parameters mentioned above. Soon after data collection text of the publication will be made. The results will be discussed with recent literature and conclusions will be made.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pat. after mpfl reconstruction | – | Procedure: mpfl reconstructionAll 45 subjects operated with mpfl reconstruction included to chek-up after follow-up. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 45 patients under 18 yo, 30 females, 15 males, average age of 15 yo
Key inclusion criteria (3 listed)
- age <18 yo
- recurrent patellar dislocation
- ready for follow-up
Key exclusion criteria (3 listed)
- age <18 yo
- osteochondral fracture
- habitual dislocation
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 |
|---|---|---|
| mpfl reconstructionHarvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw. | Procedure or surgery | Pat. after mpfl reconstruction |
Primary outcome
Dislocation recurrence
Time frame: 2 years
The incident of patellar dislocation after treatment
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 12 Feb 2021.
- Individual participant dataSharing planned: Yes. Sharing IPD after data collection in Exel
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.
Kryspin Niedzielski, Ph.D. study chair
Polish Mother Memorial Hospital Research Institute
Krzysztof Małecki, Ph.D. study director
Polish Mother Memorial Hospital Research Institute
Jacek Beczkowski, M.D. principal investigator
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 3 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 12 Feb 2021. 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?
Dislocation recurrence (time frame: 2 years). 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 12 Feb 2021.