Patellofemoral DislocationBioPPDNCT06169800
Biologic Augment of the Medial Patellofemoral Ligament Following Primary Lateral Patellofemoral Dislocation (BioPPD)
A study testing MPFL repair with Biobrace augmentation in people with Patellofemoral Dislocation, run by Banff Sport Medicine Foundation at 1 site in Canada.
Trial summary
This study aims to determine the ability of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Patellofemoral Dislocation
- What is being tested?
- MPFL repair with Biobrace augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13 - 30 years
- First-time lateral patellofemoral dislocation in the previous 7 days
- Closed or closing growth plates (confirmed on knee x-rays with no change required for surgical technique)
Who cannot join
- History of previous patellofemoral dislocation on the index knee
- An osteochondral fracture of the patellofemoral joint that requires surgical repair
- Unable to complete computer-based outcome questionnaires
- Pregnant at the time of surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Banff Sport Medicine
Canmore, Alberta, T1W 0L5
Laurie Hiemstra, MD PhD FRCSC, 403-760-2897, hiemstra@banffsportmed.ca
About this study
Official title: A Pilot Study to Evaluate the Effectiveness of a Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After a Primary Lateral Patellofemoral Dislocation (BioPPD)
This study aims to determine the ability of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. First-time patellofemoral dislocation is a significant problem, and the ramifications of recurrence for patients are substantial. Due to the multifactorial nature of the pathoanatomy of patellofemoral instability, it has been difficult to design trials that will show how interventions could affect the natural history of these young patients. No definitive studies have determined whether the surgical reconstruction of the MPFL in patients with mild to moderate pathoanatomic risk factors will decrease the re-dislocation rate after a first-time dislocation. In addition, to date, no synthetic option has provided both biology and strength for ligament augmentation. This innovation may allow for a minimalist approach to keeping the patella centred in the trochlear groove during the healing phase after a first-time dislocation.
Read the detailed description
This study aims to determine the ability of MPFL repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. The null hypothesis is that there will be no difference in re-dislocation rate 2 years after surgical stabilization with Biobrace® compared to the natural history of patellar instability.
Patellofemoral instability is a well-recognized and common knee joint injury. Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80%. Recurrence varies depending on the unique pathoanatomic risk factors of each patient. Risk factors related to recurrence after a first-time dislocation include open growth plates, age at first dislocation, trochlear dysplasia, increased tibial tubercle - trochlear groove (TT-TG) distance, contralateral dislocation, and patella alta. A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30%.
The MPFL plays a critical role in the constraint of lateral translation of the patella, providing 50-60% of the soft tissue restraint in early flexion before the patella engages in the trochlear groove. Essentially, the MPFL guides and holds the patella in the trochlear groove, especially between 0-45 degrees of flexion. MPFL insufficiency is present in as many as 90% of acute patellar dislocations and up to 100% of recurrent cases. The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension, which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position.
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation. To date, the type of knee immobilization has not been demonstrated to influence the recurrence rate. Operative management has been investigated compared to traditional non-operative treatment. A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair. Liebensteiner et al. reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear. Despite these published results, surgical treatment after a first-time dislocation has not found widespread acceptance.
Further trials have compared MPFL repair to MPFL reconstruction. Bitar et al. conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction. These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella. Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment. This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability.
Synthetic products can be used as a graft to reconstruct an MPFL. A systematic review has reported good results at a minimum of 2 years post-operative. Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms: they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair. The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace® implant by Biorez. The Biobrace® implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists. The Biobrace® implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery.
- Conditions
- Patellofemoral Dislocation
- Being tested
- MPFL repair with Biobrace augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL repair with Biobrace augmentationDevice
MPFL repair with Biobrace augmentation
| Study group | Role | What they receive |
|---|---|---|
| MPFL repair with Biobrace augmentation | Experimental | Patients presenting with first-time lateral patellofemoral dislocation within the previous 7 days will be offered a patellofemoral stabilization procedure, including knee arthroscopy and an MPFL repair augmented with Biobrace® synthetic ligament. Receives: Device: MPFL repair with Biobrace augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Dislocation of the Patella
Reports of patellar dislocation will be recorded during the follow-up visits, and a clinical assessment of patellar mobility will be completed to assess the integrity of the MPFL to confirm the redislocation. The rate of re-dislocation will be calculated and compared with the published 30% recurrence rate for patients managed conservatively following a first-time patellar dislocation. A relative risk and risk difference of re-dislocation will be calculated.
Measured: 2-years
Secondary outcomes (9)
Banff Patellofemoral Instability Instrument (BPII 2.0)
The BPII 2.0 is a valid and reliable, disease-specific quality-of-life score with five domains, including symptoms and physical complaints; work-related concerns; sport, recreation, and competition; lifestyle; and social and emotional. This patient-reported outcome will be assessed before surgery, and 6, 12, and 24 months after surgery. Score range 0-100, with higher score indicative of higher quality of life.
Measured: 2-years
Single-leg Hop tests
The hop tests involve a comparative assessment of limb-to-limb function for a single hop for distance, a 6-metre timed hop, a triple hop for distance, and a triple cross-over hop at 6, 12, and 24 months after surgery.
Measured: 2-years
Single-leg Balance test
Single-leg balance on a Bosu ball will be assessed for each limb to a maximum time of 30 seconds at 6, 12, and 24 months after surgery.
Measured: 2-years
Isometric Muscle Strength
A crane gauge will be used to measure quadriceps and hamstrings strength in kilograms before surgery and 6, 12, and 24 months after surgery.
Measured: 2-years
Recurrent Instability of the Patella (RIP) Score
The RIP score uses age, skeletal maturity, trochlear dysplasia, and TT-TG/PL ratio to predict recurrence. This score can categorize patients into low, intermediate, and high risk for re-dislocation.
Measured: 2-years
Visual analogue scale (VAS) pain scores in the initial 14-days post-operative
A log book will be used to record VAS pain scores twice daily for the first 14 days post-operative. The score will be marked on a 100mm line where o represents no pain and 100 represents severe pain.
Measured: 2-weeks
Medication use in the initial 14-days post-operative
A log book will be used to record medication use for the first 14 days post-operative. Patients will indicate the medications used and the dose consumed each day.
Measured: 2-weeks
Tampa Kinesiophobia Scale (TSK-11)
Patient-reported outcome measure of kinesiophobia using the TSK-11 will completed pre-operatively and 6, 12, and 24 months post-operative. The minimum score is 11 and the maximum score is 44, with higher scores indicative of greater kinesiophobia.
Measured: 2-years
ACL Return to Sport after Injury (ACL-RSI)
Patient-reported outcome measure for return to sport using the ACL-RSI will completed pre-operatively and 6, 12, and 24 months post-operative. The minimum score is 0 and the maximum score is 100. Higher scores indicate greater psychological preparation for return to sport.
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 posted14 Dec 2023
- Study start15 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral 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
- Not applicable
- Intervention model
- Single group
- Model description
- This investigator-initiated pilot trial will assess patients with a first-time lateral patellofemoral dislocation following surgical MPFL repair augmented with a Biobrace®. Patients will be evaluated for two years post-operative, using patient-reported outcome measures and objective clinical and functional testing.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banff Sport Medicine Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Sponsor
- Investigators
- Laurie A Hiemstra, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169800
- Sponsor's protocol ID
- REB23-1095
- Acronym
- BioPPD
- Status last verified
- Jan 2025
- First submitted
- 5 Dec 2023
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effectiveness of a Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After a Primary Lateral Patellofemoral Dislocation (BioPPD)
- ClinicalTrials.gov ID
- NCT06169800
- Acronym / sponsor ID
- BioPPD / REB23-1095
- Conditions
- Patellofemoral Dislocation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Banff Sport Medicine FoundationUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Dec 2023 (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 aims to determine the ability of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. First-time patellofemoral dislocation is a significant problem, and the ramifications of recurrence for patients are substantial. Due to the multifactorial nature of the pathoanatomy of patellofemoral instability, it has been difficult to design trials that will show how interventions could affect the natural history of these young patients. No definitive studies have determined whether the surgical reconstruction of the MPFL in patients with mild to moderate pathoanatomic risk factors will decrease the re-dislocation rate after a first-time dislocation. In addition, to date, no synthetic option has provided both biology and strength for ligament augmentation. This innovation may allow for a minimalist approach to keeping the patella centred in the trochlear groove during the healing phase after a first-time dislocation.
Detailed description
This study aims to determine the ability of MPFL repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. The null hypothesis is that there will be no difference in re-dislocation rate 2 years after surgical stabilization with Biobrace® compared to the natural history of patellar instability.
Patellofemoral instability is a well-recognized and common knee joint injury. Studies reporting the natural history after a first-time patellofemoral dislocation have reported a recurrence rate ranging from 10-80%. Recurrence varies depending on the unique pathoanatomic risk factors of each patient. Risk factors related to recurrence after a first-time dislocation include open growth plates, age at first dislocation, trochlear dysplasia, increased tibial tubercle - trochlear groove (TT-TG) distance, contralateral dislocation, and patella alta. A recent systematic review and meta-analysis determined the redislocation rate in patients managed without surgery after a first-time dislocation was 30%.
The MPFL plays a critical role in the constraint of lateral translation of the patella, providing 50-60% of the soft tissue restraint in early flexion before the patella engages in the trochlear groove. Essentially, the MPFL guides and holds the patella in the trochlear groove, especially between 0-45 degrees of flexion. MPFL insufficiency is present in as many as 90% of acute patellar dislocations and up to 100% of recurrent cases. The traditional non-operative treatment for a first-time dislocation has been to splint the knee in extension, which may prevent further dislocation but does not reduce the patella in the trochlear groove so that the medial soft tissue can heal in an anatomic position.
Multiple studies have investigated operative and non-operative treatments that aim to reduce recurrence after a first-time patellofemoral dislocation. To date, the type of knee immobilization has not been demonstrated to influence the recurrence rate. Operative management has been investigated compared to traditional non-operative treatment. A systematic review tabulated 15 studies comparing MPFL repair to non-operative management demonstrated decreased re-dislocation rates and decreased knee pain in those with surgical repair. Liebensteiner et al. reviewed studies with level 1 or 2 evidence and concluded that there are mixed results and that consensus on the ideal management after a first-time dislocation is still unclear. Despite these published results, surgical treatment after a first-time dislocation has not found widespread acceptance.
Further trials have compared MPFL repair to MPFL reconstruction. Bitar et al. conducted a study of MPFL reconstruction compared to non-operative management using the current a la carte indications for isolated MPFL reconstruction. These authors concluded that MPFL reconstruction was superior for preventing re-dislocation of the patella. Another recent retrospective review of 76 patients with an osteochondral lesion followed for 2 years compared MPFL-R to MPFL repair or no treatment. This study determined that completing an MPFL-R at index surgery resulted in a 5-fold reduction in recurrent instability.
Synthetic products can be used as a graft to reconstruct an MPFL. A systematic review has reported good results at a minimum of 2 years post-operative. Most synthetic products available today to augment or enhance the repair of ligaments are designed to address only one of two failure mechanisms: they either add mechanical strength without biological healing or aid in remodelling the underlying tendon tissue without providing mechanical strength during surgical repair. The inability of current devices to both strengthen the repair and create a favourable healing environment for cellular infiltration and tissue growth has led to further innovation and the development of the Biobrace® implant by Biorez. The Biobrace® implant is intended for use in general surgical procedures to reinforce soft tissue where weakness exists. The Biobrace® implant is also designed to reinforce soft tissues repaired by suture or suture anchors during tendon or ligament repair surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This investigator-initiated pilot trial will assess patients with a first-time lateral patellofemoral dislocation following surgical MPFL repair augmented with a Biobrace®. Patients will be evaluated for two years post-operative, using patient-reported outcome measures and objective clinical and functional testing.
| Arm | Type | Receives |
|---|---|---|
| MPFL repair with Biobrace augmentation | Experimental | Device: MPFL repair with Biobrace augmentationPatients presenting with first-time lateral patellofemoral dislocation within the previous 7 days will be offered a patellofemoral stabilization procedure, including knee arthroscopy and an MPFL repair augmented with Biobrace® synthetic ligament. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 13 - 30 years
- First-time lateral patellofemoral dislocation in the previous 7 days
- Closed or closing growth plates (confirmed on knee x-rays with no change required for surgical technique)
Key exclusion criteria (4 listed)
- History of previous patellofemoral dislocation on the index knee
- An osteochondral fracture of the patellofemoral joint that requires surgical repair
- Unable to complete computer-based outcome questionnaires
- Pregnant at the time of surgery
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 repair with Biobrace augmentationMPFL repair with Biobrace augmentation | Device | MPFL repair with Biobrace augmentation |
Primary outcome
Recurrent Dislocation of the Patella
Time frame: 2-years
Reports of patellar dislocation will be recorded during the follow-up visits, and a clinical assessment of patellar mobility will be completed to assess the integrity of the MPFL to confirm the redislocation. The rate of re-dislocation will be calculated and compared with the published 30% recurrence rate for patients managed conservatively following a first-time patellar dislocation. A relative risk and risk difference of re-dislocation will be calculated.
9 secondary outcomes
Banff Patellofemoral Instability Instrument (BPII 2.0)
Time frame: 2-years
Single-leg Hop tests
Time frame: 2-years
Single-leg Balance test
Time frame: 2-years
Isometric Muscle Strength
Time frame: 2-years
Recurrent Instability of the Patella (RIP) Score
Time frame: 2-years
Visual analogue scale (VAS) pain scores in the initial 14-days post-operative
Time frame: 2-weeks
Medication use in the initial 14-days post-operative
Time frame: 2-weeks
Tampa Kinesiophobia Scale (TSK-11)
Time frame: 2-years
ACL Return to Sport after Injury (ACL-RSI)
Time frame: 2-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Dislocation
Active, not recruitingObservational study
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
Medial Patellofemoral Dislocation
Not yet recruiting
Comparison Between Medial Patellofemoral Ligament Reconstruction Alone Versus Combined MPFL & Medial Patellotibial Ligament Reconstruction in the Management of Recurrent Lateral Patellar Dislocation in Children
Recurrent Patellar Displacement, MPFL
RecruitingObservational study
JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
Patellar Dislocation, Recurrent, Patellar Dislocation
Recruiting
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Patellar Instability
Recruiting
SHould You TransFer the Tubercle?
Patellofemoral Dislocation, Tibial Tubercle Osteotomy
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.
Laurie A Hiemstra, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPFL repair with Biobrace augmentation in people with Patellofemoral Dislocation, run by Banff Sport Medicine Foundation at 1 site in Canada.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Oct 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie A Hiemstra, MD, PhD (403 760 2897 ext. 1, research@banffsportmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Dislocation of the Patella (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 22 Oct 2025.