Patella, Familial Recurrent Dislocation OfNCT02480959
Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability
A study testing Surgical treatment for recurrent patellar instability in people with Patella, Familial Recurrent Dislocation Of, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Patella, Familial Recurrent Dislocation Of
- What is being tested?
- Surgical treatment for recurrent patellar instability
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Dec 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recurrent lateral patellar instability has been described by the patient
- Imaging criteria include:
- TT-TG distance (on CT or MRI) is between 10-20 mm
- Insall-Salvati Index is between 0.9 - 1.2
- Trochlea angle is lower than 145 degrees
Who cannot join
- Only a single event of lateral patellar instability occured
- Imaging criteria include:
- TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm
- Insall-Salvati Index is below 0.9 or above 1.2
- Trochlea angle is above 145 degrees
- Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs
- Significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 44281
Iftach Hetsroni, M.D., 972-9-7471182, iftach.hetsroni@clalit.org.il
About this study
Official title: Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction
The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.
Read the detailed description
Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.
- Being tested
- Surgical treatment for recurrent patellar instability
- Medical subject headings
- Patella, Familial Recurrent Dislocation Of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment for recurrent patellar instabilityProcedure or surgery
Either medial plication or MPFL reconstructuion surgery
| Study group | Role | What they receive |
|---|---|---|
| Medial plication | Other | Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication Receives: Procedure: Surgical treatment for recurrent patellar instability |
| MPFL reconstruction | Other | Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft Receives: Procedure: Surgical treatment for recurrent patellar instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala knee outcome score
A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms
Measured: Between two and five years after surgery
Secondary outcomes (8)
International Knee Documentation Committee subjective outcome score
A validated international outcome score that evaluates general knee functional outcome
Measured: Between two and five years after surgery
Tenger activity level score
A validated international outcome score that evaluates highest level of sports activity
Measured: Between two and five years after surgery
Marx activity level score
A validated international outcome score that evaluates highest level of sports activity
Measured: Between two and five years after surgery
Visual Analogue Scale
A validated international scale that evaluates level of pain
Measured: Between two and five years after surgery
Single hop test
Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance
Measured: Between two and five years after surgery
Side-to-side hop test
Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds
Measured: Between two and five years after surgery
Patellar apprehension test
Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly
Measured: Between two and five years after surgery
Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage
Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage
Measured: Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella, Familial Recurrent Dislocation OfStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus, Hadassah Medical Organization, Assaf-Harofeh Medical Center, Soroka University Medical Center
- Responsible party
- Sponsor
- Investigators
- IFTACH HETSRONI, M.D., Principal investigator, Meir Medical CenterDROR LINDNER, M.D., Principal investigator, Assaf-Harofeh Medical CenterIDAN ILSAR, M.D., Principal investigator, Hadassah Medical OrganizationMAZEN FALAH, M.D., Principal investigator, Rambam Health Care CampusNASSIM ALKRINAWI, M.D., Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480959
- Sponsor's protocol ID
- 0041-15-MMC
- Status last verified
- Mar 2020
- First submitted
- 8 Jun 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02480959
- Acronym / sponsor ID
- 0041-15-MMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus, Hadassah Medical Organization, Assaf-Harofeh Medical Center, Soroka University Medical Center
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Jun 2015 (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 study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.
Detailed description
Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial plication | Other | Procedure: Surgical treatment for recurrent patellar instabilityPatient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication |
| MPFL reconstruction | Other | Procedure: Surgical treatment for recurrent patellar instabilityPatient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Recurrent lateral patellar instability has been described by the patient
- TT-TG distance (on CT or MRI) is between 10-20 mm
- Insall-Salvati Index is between 0.9 - 1.2
- Trochlea angle is lower than 145 degrees
Key exclusion criteria (7 listed)
- Only a single event of lateral patellar instability occured
- TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm
- Insall-Salvati Index is below 0.9 or above 1.2
- Trochlea angle is above 145 degrees
- Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs
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 |
|---|---|---|
| Surgical treatment for recurrent patellar instabilityEither medial plication or MPFL reconstructuion surgery | Procedure or surgery | MPFL reconstruction, Medial plication |
Primary outcome
Kujala knee outcome score
Time frame: Between two and five years after surgery
A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms
8 secondary outcomes
International Knee Documentation Committee subjective outcome score
Time frame: Between two and five years after surgery
Tenger activity level score
Time frame: Between two and five years after surgery
Marx activity level score
Time frame: Between two and five years after surgery
Visual Analogue Scale
Time frame: Between two and five years after surgery
Single hop test
Time frame: Between two and five years after surgery
Side-to-side hop test
Time frame: Between two and five years after surgery
Patellar apprehension test
Time frame: Between two and five years after surgery
Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage
Time frame: Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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.
IFTACH HETSRONI, M.D. principal investigator
Meir Medical Center
DROR LINDNER, M.D. principal investigator
Assaf-Harofeh Medical Center
IDAN ILSAR, M.D. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment for recurrent patellar instability in people with Patella, Familial Recurrent Dislocation Of, run by Meir Medical Center at 1 site in Israel.
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 5 inclusion and 7 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 4 Mar 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 Israel. 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?
Contact IFTACH HETSRONI, M.D. (972-9-747 ext. 1182, iftach.hetsroni@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala knee outcome score (time frame: Between two and five years after surgery). 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 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.