Knee StabilityNCT02180685
Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics
A study testing Anchor fixation in people with Knee Stability and Patella Luxation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Stability, Patella Luxation
- What is being tested?
- Anchor fixation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jan 2019
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patella luxation, more than 2 times
Who cannot join
- cartilage damage (grad 3)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.
- Conditions
- Knee Stability, Patella Luxation
- Being tested
- Anchor fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anchor fixationOther
| Study group | Role | What they receive |
|---|---|---|
| Anchor fixation | Other | Medial fixation of the reconstruction at the medial femural condyle with suture anchors. Receives: Other: Anchor fixation |
| Screw fixation | Other | Medial fixation of the reconstruction at the medial femural condyle with a screw. Receives: Other: Anchor fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of subjective symptoms with a patient reported outcome score
Anterior Knee Pain Scale
Measured: Baseline, 6 months 12 Months, 24 months
Secondary outcomes (3)
Patient reported outcome scores
Tegner
Measured: Baseline, 6 months 12 Months, 24 months
Patient reported outcome scores
KOOS (Knee injury and osteoarthritis outcome score)
Measured: Baseline, 6 months 12 Months, 24 months
Re-operation rate
Measured: Baseline, 6 months 12 Months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJan 2009
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee StabilityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
- NCT02180685
- Sponsor's protocol ID
- Danish EC 1-10-72-194-14
- Status last verified
- Jan 2019
- First submitted
- 30 Jun 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics
- ClinicalTrials.gov ID
- NCT02180685
- Acronym / sponsor ID
- Danish EC 1-10-72-194-14
- Conditions
- Knee Stability, Patella Luxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 Jul 2014 (estimated)
- 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 present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anchor fixation | Other | Other: Anchor fixationMedial fixation of the reconstruction at the medial femural condyle with suture anchors. |
| Screw fixation | Other | Other: Anchor fixationMedial fixation of the reconstruction at the medial femural condyle with a screw. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patella luxation, more than 2 times
Key exclusion criteria (1 listed)
- cartilage damage (grad 3)
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 |
|---|---|---|
| Anchor fixation | Other | Anchor fixation, Screw fixation |
Primary outcome
Evaluation of subjective symptoms with a patient reported outcome score
Time frame: Baseline, 6 months 12 Months, 24 months
Anterior Knee Pain Scale
3 secondary outcomes
Patient reported outcome scores
Time frame: Baseline, 6 months 12 Months, 24 months
Patient reported outcome scores
Time frame: Baseline, 6 months 12 Months, 24 months
Re-operation rate
Time frame: Baseline, 6 months 12 Months, 24 months
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 11 Jan 2019.
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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 Anchor fixation in people with Knee Stability and Patella Luxation, 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 1 inclusion and 1 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 11 Jan 2019. 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?
Evaluation of subjective symptoms with a patient reported outcome score (time frame: Baseline, 6 months 12 Months, 24 months). 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 11 Jan 2019.