Patellar DislocationMPFLNCT04673188
Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
A study testing Reconstruction of MPFL with or without tibial tuberositas osteotomy in people with Patellar Dislocation, run by Nik Žlak at 1 site in Slovenia.
Trial summary
The purpose of the study is: 1. to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- Reconstruction of MPFL with or without tibial tuberositas osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2020to Sep 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age
- surgical intervention with MPFL reconstruction
- with or without tibial tuberosity transposition (TTT).
Who cannot join
- trochleoplasty,
- corrective knee osteotomy
- reparative cartilage treatment
- reconstruction of other knee ligaments
- meniscus repair
- movement impairments
Show all 12Show fewer
- plegia
- paresis
- neuromuscular diseases
- participation rejection
- rejection to complete the control questionnaires
- lack of understanding of the Slovenian language
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
Ljubljana, 1000
About this study
The purpose of the study is:
- to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity
- to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.
- Conditions
- Patellar Dislocation
- Being tested
- Reconstruction of MPFL with or without tibial tuberositas osteotomy
- Keywords
- Medial patello femoral ligament, Patellar instability, Reconstruction, Predicting factors
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction of MPFL with or without tibial tuberositas osteotomyProcedure or surgery
Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subjective knee status evaluated with EQ-5D
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.
Measured: 2-8 years
Change of subjective knee status evaluated with KOOS
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.
Measured: 2-8 years
Change of subjective knee status on Tegner activity scale
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.
Measured: 2-8 years
Change of subjective knee status evaluated with Kujala score
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.
Measured: 2-8 years
Change of subjective knee status on IKDC
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.
Measured: 2-8 years
Secondary outcomes (1)
Patellar position change
The height of the patella in the late post-operative period is not expected to differ from its position immediately after the procedure. The patellar height will be assessed with Caton-Deschamp index on standard lateral X-rays before surgery, immediately after surgery and at least six months after surgery. Reference values for normal patellar height are 0.8 - 1.2.
Measured: 2-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2020
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nik Žlak
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University of Ljubljana
- Responsible party
- Sponsor-investigator, Nik Žlak, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673188
- Sponsor's protocol ID
- KME 0120-169/2020/4
- Acronym
- MPFL
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
- ClinicalTrials.gov ID
- NCT04673188
- Acronym / sponsor ID
- MPFL / KME 0120-169/2020/4
- Conditions
- Patellar Dislocation
- Keywords
- Medial patello femoral ligament, Patellar instability, Reconstruction, Predicting factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Nik ŽlakUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University of Ljubljana
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 17 Dec 2020 (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 purpose of the study is:
- to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity
- to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective cohort study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years of age
- surgical intervention with MPFL reconstruction
- with or without tibial tuberosity transposition (TTT).
Key exclusion criteria (12 listed)
- trochleoplasty,
- corrective knee osteotomy
- reparative cartilage treatment
- reconstruction of other knee ligaments
- meniscus repair
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 |
|---|---|---|
| Reconstruction of MPFL with or without tibial tuberositas osteotomyReconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities. | Procedure or surgery | – |
Primary outcome
Change of subjective knee status evaluated with EQ-5D
Time frame: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status evaluated with KOOS
Time frame: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status on Tegner activity scale
Time frame: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.
Change of subjective knee status evaluated with Kujala score
Time frame: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.
Change of subjective knee status on IKDC
Time frame: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.
1 secondary outcome
Patellar position change
Time frame: 2-8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction of MPFL with or without tibial tuberositas osteotomy in people with Patellar Dislocation, run by Nik Žlak at 1 site in Slovenia.
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 12 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 Slovenia. 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?
Results are not available in the source record.
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?
Change of subjective knee status evaluated with EQ-5D (time frame: 2-8 years). The study lists 5 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 17 Dec 2020.