Recurrent Patella DislocationNCT05488275
MPFL vs Campbell in Recurrent Patella Dislocation
A study testing Surgery in people with Recurrent Patella Dislocation, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Patella Dislocation
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jul 2020to 30 May 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recurrent patella dislocation
- No patellofemoral joint dysplasia or Dysplasia A/B according to Dejour (non operating)
- Acceptable is to perform concomitant medialization Tibial Tubercle Osteotomy
Who cannot join
- no informed consent to participate in the study
- age under 18 years or above 65
- multiligament injury or single plane knee instability
- another musculoskeletal disorders in lower limb
- lower limb deformity requiring axis correction: valgus
- femoral anteversion (CT measurements)
Show all 9Show fewer
- joints inflammatory diseases
- concomitant patellectomy or trochleoplasty
- ASA score > II
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400
Rafal Kaminski, MD PhD, +48227794031 ext. 469, rkaminski@spskgruca.pl
Stanislaw Pomianowski, MD PhD Prof, +48227794031 ext. 481, spom@spskgruca.pl
About this study
Official title: Prospective, Randomized, Double Blinded Trial Comparing Medial Patellofemoral Ligament Reconstruction (Hamstrings) Versus Campbell Functional Reconstruction (Non-anatomic) in Recurrent Patella Dislocation
This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes.
Read the detailed description
Recurrent patella dislocation require surgery treatment. It provides to less cartilage degeneration and slow down knee osteoarthritis. Medial retinacular complex is injured in first time patella dislocation and its reconstruction is necessary. In literature there can be found many surgical reconstruction technics: anatomical or non anatomical (functional). But there is lack of evidence which technic provides to better outcomes - reduce the possibility to patella dislocation and progression of osteoarthritis in patellofemoral joint. Nowadays the choice of performed surgery depends on surgeons personal assessment.
- Conditions
- Recurrent Patella Dislocation
- Being tested
- Surgery
- Keywords
- MPFL, Campbell
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
MPFL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| MPFL static | Active comparator | Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure Receives: Procedure: Surgery |
| Campbell | Active comparator | Medial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method) Receives: Procedure: Surgery |
| MPFL dynamic | Active comparator | Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging modality X-ray
Patellofemoral Joints Biomechanics improvement measured by patella tilt
Measured: 1 year
Imaging modality X-ray
Patellofemoral Joints Biomechanics improvement measured by Q angle
Measured: 2 years
Imaging modality CT
Patellofemoral Joints Biomechanics improvement measured by Insall-Salvati ratio. The Insall-Salvati ratio or index is the ratio of the patella tendon length to the length of the patella and is used to determine patellar height. he Insall-Salvati ratio was initially determined on a 30° flexed lateral knee x-ray and was later applied to sagittal MRI.
Distance lines are used to calculate Insall-Salvati ratio:
A: patellar tendon length (TL): length of the posterior surface of the tendon from the lower pole of the patella to its insertion on the tibia B: patellar length (PL): greatest pole-to-pole length Insall-Salvati ratio = A/B (or TL/PL). patella baja: <0.8 normal: 0.8-1.2 patella alta: >1.2
Measured: 2 years
Imaging modality CT
Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove)
Measured: 2 years
Secondary outcomes (27)
Functional tests
hop-for-distance
Measured: 12 weeks
Functional tests
hop-for-distance
Measured: 6 months
Functional tests
hop-for-distance
Measured: 12 months
Functional tests
hop-for-distance
Measured: 24 months
Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 12 weeks,
Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score;The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 6 months,
Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score; The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 12 months
Knee Injury and Osteoarthritis Outcome Score
Knee Injury and Osteoarthritis Outcome Score;The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).
Measured: 24 months
International Knee Documentation Committee
IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function.
Measured: 12 weeks
International Knee Documentation Committee
IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function.
Measured: 6 months
International Knee Documentation Committee
IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function.
Measured: 12 months
International Knee Documentation Committee
IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function.
Measured: 24 months
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 12 weeks,
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 6 months,
Tegner Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: 12 months
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 12 weeks,
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 6 months,
Pain Visual Analog Scale.
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 12 months,
Pain Visual Analog Scale
The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best).
Measured: 24 months
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability
Measured: 12 weeks
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability
Measured: 6 months,
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability
Measured: 12 months
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability
Measured: 24 months
The Victorian Institute of Sport Assessment
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic
Measured: 12 weeks,
The Victorian Institute of Sport Assessment
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic
Measured: 6 months,
The Victorian Institute of Sport Assessment
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic
Measured: 12 months,
The Victorian Institute of Sport Assessment
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start15 Jul 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafał Kamiński, Principal investigator, PCME, Otwock, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488275
- Sponsor's protocol ID
- mpfl_campbell
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2020
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blinded Trial Comparing Medial Patellofemoral Ligament Reconstruction (Hamstrings) Versus Campbell Functional Reconstruction (Non-anatomic) in Recurrent Patella Dislocation
- ClinicalTrials.gov ID
- NCT05488275
- Acronym / sponsor ID
- mpfl_campbell
- Conditions
- Recurrent Patella Dislocation
- Keywords
- MPFL, Campbell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 4 Aug 2022 (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.
This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes.
Detailed description
Recurrent patella dislocation require surgery treatment. It provides to less cartilage degeneration and slow down knee osteoarthritis. Medial retinacular complex is injured in first time patella dislocation and its reconstruction is necessary. In literature there can be found many surgical reconstruction technics: anatomical or non anatomical (functional). But there is lack of evidence which technic provides to better outcomes - reduce the possibility to patella dislocation and progression of osteoarthritis in patellofemoral joint. Nowadays the choice of performed surgery depends on surgeons personal assessment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPFL static | Active comparator | Procedure: SurgeryMedial Patellofemoral Ligament reconstruction with hamstring graft - static procedure |
| Campbell | Active comparator | Procedure: SurgeryMedial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method) |
| MPFL dynamic | Active comparator | Procedure: SurgeryMedial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent patella dislocation
- No patellofemoral joint dysplasia or Dysplasia A/B according to Dejour (non operating)
- Acceptable is to perform concomitant medialization Tibial Tubercle Osteotomy
Key exclusion criteria (9 listed)
- no informed consent to participate in the study
- age under 18 years or above 65
- multiligament injury or single plane knee instability
- another musculoskeletal disorders in lower limb
- lower limb deformity requiring axis correction: valgus
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 |
|---|---|---|
| SurgeryMPFL reconstruction | Procedure or surgery | Campbell, MPFL dynamic, MPFL static |
Primary outcome
Imaging modality X-ray
Time frame: 1 year
Patellofemoral Joints Biomechanics improvement measured by patella tilt
Imaging modality X-ray
Time frame: 2 years
Patellofemoral Joints Biomechanics improvement measured by Q angle
Imaging modality CT
Time frame: 2 years
Patellofemoral Joints Biomechanics improvement measured by Insall-Salvati ratio. The Insall-Salvati ratio or index is the ratio of the patella tendon length to the length of the patella and is used to determine patellar height. he Insall-Salvati ratio was initially determined on a 30° flexed lateral knee x-ray and was later applied to sagittal MRI. Distance lines are used to calculate Insall-Salvati ratio: A: patellar tendon length (TL): length of the posterior surface of the tendon from the lower pole of the patella to its insertion on the tibia B: patellar length (PL): greatest pole-to-pole length Insall-Salvati ratio = A/B (or TL/PL). patella baja: <0.8 normal: 0.8-1.2 patella alta: >1.2
Imaging modality CT
Time frame: 2 years
Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove)
27 secondary outcomes
Functional tests
Time frame: 12 weeks
Functional tests
Time frame: 6 months
Functional tests
Time frame: 12 months
Functional tests
Time frame: 24 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: 12 weeks,
Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 months,
Knee Injury and Osteoarthritis Outcome Score
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: 24 months
International Knee Documentation Committee
Time frame: 12 weeks
International Knee Documentation Committee
Time frame: 6 months
International Knee Documentation Committee
Time frame: 12 months
International Knee Documentation Committee
Time frame: 24 months
Tegner Lysholm Knee Scoring Scale
Time frame: 12 weeks,
Tegner Lysholm Knee Scoring Scale
Time frame: 6 months,
Tegner Lysholm Knee Scoring Scale
Time frame: 12 months
Pain Visual Analog Scale
Time frame: 12 weeks,
Pain Visual Analog Scale
Time frame: 6 months,
Pain Visual Analog Scale.
Time frame: 12 months,
Pain Visual Analog Scale
Time frame: 24 months
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Time frame: 12 weeks
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Time frame: 6 months,
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Time frame: 24 months
The Victorian Institute of Sport Assessment
Time frame: 12 weeks,
The Victorian Institute of Sport Assessment
Time frame: 6 months,
The Victorian Institute of Sport Assessment
Time frame: 12 months,
The Victorian Institute of Sport Assessment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
Related trials for Recurrent Patella Dislocation
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
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.
Rafał Kamiński principal investigator
PCME, Otwock, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Recurrent Patella Dislocation, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 3 inclusion and 9 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 15 Aug 2022. 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 Poland. 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 Rafał Kamiński (+48227794031 ext. 469, rkaminski@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging modality X-ray (time frame: 1 year). The study lists 4 primary outcomes in all. 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 15 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.