Patella-DislocationNCT00816647
A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction
A study testing Patellofemoral stabilizing surgery in people with Patella-Dislocation and Patellofemoral Osteoarthritis, run by Finnish Defense Forces at 1 site in Finland.
Trial summary
The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patella-Dislocation, Patellofemoral Osteoarthritis, Patellar Instability
- What is being tested?
- Patellofemoral stabilizing surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2008to Jun 2011
- 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
- Chronic patellar instability (more than 2 dislocations)
- Minimum 6 months nonoperative treatment
Who cannot join
- Severe PF OA
- Acute patellar dislocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing
The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.
Read the detailed description
Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.
- Being tested
- Patellofemoral stabilizing surgery
- Keywords
- Patella, Dislocation, Knee, Medial Patellofemoral Ligament
- Medical subject headings
- Patellar Dislocation, Patella Fracture, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellofemoral stabilizing surgeryProcedure or surgery
Comparison of surgical techniques
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Medial patellofemoral ligament reconstruction Receives: Procedure: Patellofemoral stabilizing surgery |
| 2 | Active comparator | Medial reefing Receives: Procedure: Patellofemoral stabilizing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent patellar instability
Measured: 2 years
Secondary outcomes (1)
Patellofemoral osteoarthrosis progression.
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 posted1 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella-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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Defense Forces
- Sponsor type
- Other government
- Collaborators
- Tampere University Hospital
- Investigators
- Petri J Sillanpaa, M.D., PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816647
- Sponsor's protocol ID
- MPFL08
- Status last verified
- Jul 2009
- First submitted
- 31 Dec 2008
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing
- ClinicalTrials.gov ID
- NCT00816647
- Acronym / sponsor ID
- MPFL08
- Keywords
- Patella, Dislocation, Knee, Medial Patellofemoral Ligament
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Finnish Defense ForcesOther government
- Collaborators
- Tampere University Hospital
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 1 Jan 2009 (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 operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.
Detailed description
Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Patellofemoral stabilizing surgeryMedial patellofemoral ligament reconstruction |
| 2 | Active comparator | Procedure: Patellofemoral stabilizing surgeryMedial reefing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic patellar instability (more than 2 dislocations)
- Minimum 6 months nonoperative treatment
Key exclusion criteria (2 listed)
- Severe PF OA
- Acute patellar 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 |
|---|---|---|
| Patellofemoral stabilizing surgeryComparison of surgical techniques | Procedure or surgery | 1, 2 |
Primary outcome
Recurrent patellar instability
Time frame: 2 years
1 secondary outcome
Patellofemoral osteoarthrosis progression.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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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.
Petri J Sillanpaa, M.D., PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patellofemoral stabilizing surgery in people with Patella-Dislocation and Patellofemoral Osteoarthritis, run by Finnish Defense Forces at 1 site in Finland.
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 2 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: stopped early, as of the sponsor's last update on 14 Jun 2011. 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 Finland. 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 was stopped early (reason given: Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.). 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?
Recurrent patellar instability (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 14 Jun 2011.