Joint InstabilityMPFLNCT02263807
Knee Function in Patients With Two or More Episodes of Patella Dislocations
A study testing MPFL Group in people with Joint Instability, run by Asbjorn Aroen at 2 sites in Norway.
Trial summary
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Instability
- What is being tested?
- MPFL Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesNorway
- Study dates
- May 2010to Jan 2022
- 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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- More than one luxation
- Norwegian citizens
- Unilateral problems
- Age range 12-30 years
Who cannot join
- -Generalized degenerative changes
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Lørenskog, 1476
Akershus University Hospital
Lørenskog, 1478
About this study
Official title: RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.
Read the detailed description
Introduction:
Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.
Aim:
The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.
Materials and methods:
Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.
- Conditions
- Joint Instability
- Being tested
- MPFL Group, Control
- Keywords
- Patella luxation
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL GroupProcedure or surgery
Also called MPFL surgery
MPFL reconstruction or standard treatment followed by physiotherapy
ControlProcedure or surgery
Also called Arthroscopy
Arthroscopy followed by active rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| MPFL group | Experimental | Arthroscopy and MPFL reconstruction Receives: Procedure: MPFL Group; Procedure: Control |
| Control | Active comparator | Arhroscopy and rehabilitation Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Numbers of reoperation in the two treatment groups
Measured: 2011-2022
Secondary outcomes (1)
Patella reluxation
Number of reluxation of patella in the two treatment groups
Measured: 2011-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMay 2010
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint InstabilityStudies 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
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asbjorn Aroen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Asbjørn Årøen, MD,PhD, Study chair, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263807
- Sponsor's protocol ID
- 2009/2148
- Acronym
- MPFL
- Status last verified
- Oct 2022
- First submitted
- 22 Dec 2011
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.
PubMed 31286929Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.
PubMed 35347375Straume-Naesheim TM, Randsborg PH, Nilsgard TL, Aroen A. Medial Patellofemoral Ligament Reconstruction vs Nonoperative Treatment for Recurrent Lateral Patellar Dislocation: Three-Year Results From a Randomized Controlled Trial. Am J Sports Med. 2026 Mar;54(4):773-779. doi: 10.1177/03635465261416931. Epub 2026 Feb 8.
PubMed 41655186Nilsgard TL, Oiestad BE, Randsborg PH, Aroen A, Straume-Naesheim TM. Association between single leg hop tests and patient reported outcome measures and patellar instability in patients with recurrent patellar dislocations. BMJ Open Sport Exerc Med. 2023 Dec 30;9(4):e001760. doi: 10.1136/bmjsem-2023-001760. eCollection 2023.
PubMed 38170085
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations
- ClinicalTrials.gov ID
- NCT02263807
- Acronym / sponsor ID
- MPFL / 2009/2148
- Conditions
- Joint Instability
- Keywords
- Patella luxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Asbjorn AroenUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 13 Oct 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.
Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.
Detailed description
Introduction:
Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.
Aim:
The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.
Materials and methods:
Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFL group | Experimental | Procedure: MPFL Group, Procedure: ControlArthroscopy and MPFL reconstruction |
| Control | Active comparator | Procedure: ControlArhroscopy and rehabilitation |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- More than one luxation
- Norwegian citizens
- Unilateral problems
- Age range 12-30 years
Key exclusion criteria (1 listed)
- -Generalized degenerative changes
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 GroupAlso: MPFL surgeryMPFL reconstruction or standard treatment followed by physiotherapy | Procedure or surgery | MPFL group |
| ControlAlso: ArthroscopyArthroscopy followed by active rehabilitation | Procedure or surgery | Control, MPFL group |
Primary outcome
Reoperation
Time frame: 2011-2022
Numbers of reoperation in the two treatment groups
1 secondary outcome
Patella reluxation
Time frame: 2011-2022
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 27 Oct 2022.
- Results publication: PubMed 31286929Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.
- Results publication: PubMed 35347375Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.
- Derived from this study: PubMed 41655186Straume-Naesheim TM, Randsborg PH, Nilsgard TL, Aroen A. Medial Patellofemoral Ligament Reconstruction vs Nonoperative Treatment for Recurrent Lateral Patellar Dislocation: Three-Year Results From a Randomized Controlled Trial. Am J Sports Med. 2026 Mar;54(4):773-779. doi: 10.1177/03635465261416931. Epub 2026 Feb 8.
- Derived from this study: PubMed 38170085Nilsgard TL, Oiestad BE, Randsborg PH, Aroen A, Straume-Naesheim TM. Association between single leg hop tests and patient reported outcome measures and patellar instability in patients with recurrent patellar dislocations. BMJ Open Sport Exerc Med. 2023 Dec 30;9(4):e001760. doi: 10.1136/bmjsem-2023-001760. eCollection 2023.
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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.
Asbjørn Årøen, MD,PhD study chair
University Hospital, Akershus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPFL Group in people with Joint Instability, run by Asbjorn Aroen at 2 sites in Norway.
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 4 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Reoperation (time frame: 2011-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263807, which also lists 4 linked publications.
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 27 Oct 2022.