Patellar DislocationNCT05706363
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
A study testing Quadriceps graft in people with Patellar Dislocation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the… Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- Quadriceps graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2017to 30 Jul 2026
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
- The growth zones must be found closed - verified by MRI scan
Who cannot join
- Patients with known rheumatoid arthritis.
- Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
- Inability to follow a normal rehabilitation regime.
- Previous ligament surgery in injured knees.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
Official title: Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.
The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.
It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.
- Conditions
- Patellar Dislocation
- Being tested
- Quadriceps graft
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps graftProcedure or surgery
Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor
| Study group | Role | What they receive |
|---|---|---|
| MPFL reconstruction with gracillis graft | Active comparator | MPFL reconstructrion with gracillis graft and screw fixation in femur Receives: Procedure: Quadriceps graft |
| MPFL reconstruction with quadriceps graft | Experimental | MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur Receives: Procedure: Quadriceps graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala (Anterior Knee Pain Scale)
Patient reported outcome score, 0=worst and 100=best
Measured: 24 month
Secondary outcomes (6)
Donor site morbidity score, 0=worst and 100=best
Patient reported outcome score
Measured: 24 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome score, 0=worst and 100=best
Measured: 24 month
Lysholm-Tegner (Activity Score)
Patient reported outcome score, 0=worst and 100=best
Measured: 24 month
Numerical Rating Scale (NRS-pain score)
Patient reported outcome score, 0=Best and 10=worst
Measured: 24 month
Knee pain
Palpatory pain in relation to graft fixation in femur on a four-point likert scale (no pain, mild pain, moderate pain, severe pain)
Measured: 24 month
Patella Re-luxation sensation
Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation).
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jul 2017
- Primary completion5 Jul 2024
- Study completion30 Jul 2026
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.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Standard: Gracillis graft 2. Intervention: Quadriceps graft
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706363
- Sponsor's protocol ID
- Danish EC: 1-10-72-75-17
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2023
- Last updated
- 28 Oct 2026
- Results posted
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05706363
- Acronym / sponsor ID
- Danish EC: 1-10-72-75-17
- Conditions
- Patellar Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 31 Jan 2023 (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 this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used.
It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Standard: Gracillis graft 2. Intervention: Quadriceps graft
| Arm | Type | Receives |
|---|---|---|
| MPFL reconstruction with gracillis graft | Active comparator | Procedure: Quadriceps graftMPFL reconstructrion with gracillis graft and screw fixation in femur |
| MPFL reconstruction with quadriceps graft | Experimental | Procedure: Quadriceps graftMPFL reconstructrion with quadriceps graft and suture anchor fixation in femur |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
- The growth zones must be found closed - verified by MRI scan
Key exclusion criteria (4 listed)
- Patients with known rheumatoid arthritis.
- Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
- Inability to follow a normal rehabilitation regime.
- Previous ligament surgery in injured knees.
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 |
|---|---|---|
| Quadriceps graftUsing quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor | Procedure or surgery | MPFL reconstruction with gracillis graft, MPFL reconstruction with quadriceps graft |
Primary outcome
Kujala (Anterior Knee Pain Scale)
Time frame: 24 month
Patient reported outcome score, 0=worst and 100=best
6 secondary outcomes
Donor site morbidity score, 0=worst and 100=best
Time frame: 24 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 month
Lysholm-Tegner (Activity Score)
Time frame: 24 month
Numerical Rating Scale (NRS-pain score)
Time frame: 24 month
Knee pain
Time frame: 24 month
Patella Re-luxation sensation
Time frame: 24 month
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 28 Oct 2026.
- 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 Quadriceps graft in people with Patellar Dislocation, run by Aarhus University Hospital at 1 site in Denmark.
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 2 inclusion and 4 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 28 Oct 2026. 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 Denmark. 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?
Kujala (Anterior Knee Pain Scale) (time frame: 24 month). 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 28 Oct 2026.