Patellofemoral DislocationSHYFTNCT05759039
SHould You TransFer the Tubercle?
A study testing Medial patellofemoral ligament reconstruction and Tibial tubercle osteotomy in people with Patellofemoral Dislocation and Tibial Tubercle Osteotomy, run by Banff Sport Medicine Foundation at 1 site in Canada.
Trial summary
The aim of this study is to investigate the role of tibial tubercle osteotomy (TTO) on the subjective and objective outcomes following medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance with or without patella alta. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Patellofemoral Dislocation, Tibial Tubercle Osteotomy, Medial Patellofemoral Ligament Reconstruction
- What is being tested?
- Medial patellofemoral ligament reconstruction and Tibial tubercle osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Sep 2026
- 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
- Symptomatic recurrent lateral patellofemoral instability
- TT-TG ≥15mm measured on MRI or ≥18mm on CT scan
- Closed physes (confirmed on knee x-rays)
Who cannot join
- Caton-Deschamps ratio ≥ 1.4 on lateral radiographs
- Femoral anteversion ≥ 25 degrees on diagnostic imaging rotational profile
- Tibial external rotation ≥ 45 degrees on diagnostic imaging rotational profile
- High-grade trochlear dysplasia requiring trochleoplasty
- Significant osteoarthritis on skyline plain imaging (Kellgren Lawrence grade ≥ 2)
- A chondral lesion of the patellofemoral joint that is undergoing a cartilage restoration procedure.
- Unable to complete computer-based outcome questionnaires
- Pregnant (at 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, 4037602897
About this study
Official title: A Randomized Clinical Pilot Trial Comparing Isolated Medial Patellofemoral Ligament Reconstruction to Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tubercle Osteotomy: SHould You TransFer the Tubercle (SHYFT)?
The aim of this study is to investigate the role of tibial tubercle osteotomy (TTO) on the subjective and objective outcomes following medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance with or without patella alta.
This Pilot RCT will assess the feasibility of conducting this study for:
- The ability to recruit study patients
- Adherence to the study protocol
- Completion rates of patient follow-up at a minimum of 12 months post-operative
Read the detailed description
For patients with recurrent lateral patellofemoral instability, a medial patellofemoral ligament reconstruction (MPFL-R) consistently provides significant improvements in symptoms, quality of life, and return to sport. During an MPFL-R the surgeon will place a soft tissue graft from the medial patella to the femur. The graft used to create the new MPFL can be autograft (usually hamstring tendon) or allograft.
The tibial tubercle osteotomy (TTO) is a procedure designed to change the vector of the pull of the quadricep muscles by moving the insertion point of the patellar tendon. This is achieved by transferring the tendon with a block of bone to allow for consistent and reliable healing. The TTO is a versatile procedure that can move the patellar tendon insertion medially, anteriorly, or distally, or a combination of these directions. It can be used to correct a lateralized tibial tubercle or patella alta.
Despite the association of an increased TT-TG distance with patellofemoral instability, it has been difficult to demonstrate a correlation with patient outcomes after patellar stabilisation surgery. In addition, studies have been unable to correlate the pre-operative presence of patella alta with clinical outcomes after MPFL-R.
This randomized clinical pilot trial will randomly allocate patients with lateral patellofemoral instability and an elevated TT-TG distance with or without patella alta ato receive either an isolated MPFL-R or an MPFL-R in combination with a correcting TTO (medializing, distalizing, or a combination of both).
Patients will be followed for two years post-operative with subjective outcome measures and objective clinical and functional testing.
The study groups will be:
- Isolated MPFL-R
- MPFL-R with a TTO
The primary outcome measures will be:
- Number of study patients recruited
- Adherence to the study protocol (number of protocol deviations)
- Follow-up completion rates of study patients at a minimum of 12 months post-operative
Secondary outcome measures include the Banff Patellar Instability Instrument 2.0 (BPII 2.0), functional testing, clinical assessment, complications, re-dislocation rate, post-operative pain scores, patient satisfaction, and patient-reported outcome scores.
If feasibility is demonstrated via this Pilot RCT, a larger RCT will be designed to answer important questions on how to optimize outcomes and limit morbidity after MPFL-R.
- Conditions
- Patellofemoral Dislocation, Tibial Tubercle Osteotomy, Medial Patellofemoral Ligament Reconstruction
- Being tested
- Medial patellofemoral ligament reconstruction, Tibial tubercle osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial patellofemoral ligament reconstructionProcedure or surgery
Medial patellofemoral ligament reconstruction
Tibial tubercle osteotomyProcedure or surgery
Tibial tubercle osteotomy
| Study group | Role | What they receive |
|---|---|---|
| MPFL-R | Active comparator | Medial patellofemoral ligament reconstruction Receives: Procedure: Medial patellofemoral ligament reconstruction |
| MPFL-R + TTO | Active comparator | Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy Receives: Procedure: Medial patellofemoral ligament reconstruction; Procedure: Tibial tubercle osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility - patient recruitment
Number of study patients recruited
Measured: 12-months post-operative
Study Feasibility - protocol adherence
Adherence to the study protocol (total number of protocol deviations)
Measured: 12-months post-operative
Study Feasibility - follow-up completion
Number of patients completing follow-up a minimum of 12 months post-operative
Measured: 12-months post-operative
Secondary outcomes (6)
Banff Patellofemoral Instability Instrument (BPII 2.0)
Disease-specific patient-reported outcome measure that assesses quality of life across 5 domains. Scored out of 100, with 100 representing the maximum score for disease-specific quality of life.
Measured: Baseline, and 6-,12- & 24-months post-operative
Functional Outcomes - Hop Testing
Limb Symmetry Index on 4 single-leg hop test battery (assessed as percentage score operative / non-operative limb)
Measured: 6-, 12- & 24-months post-operative
Patellar Apprehension Test
Rate of positive patellar apprehension
Measured: 6-, 12- & 24-months post-operative
Complications
Rate of post-operative complications including infection, blood clots, reduced range of motion, persistent pain, persistent swelling, and re-dislocations
Measured: 6-, 12- & 24-months post-operative
Post-operative Knee Pain
Post-operative pain score measured on a 10-point visual analogue scale
The Pain VAS is anchored by 0, which corresponds to "no pain", and 10, which corresponds to the "worst possible pain".
Measured: 6-, 12- & 24-months post-operative
Patient satisfaction
Measured on a 5-point Likert scale
A 5-point patient satisfaction scale measures patient happiness with healthcare services, ranging from 5 (very satisfied) to 1 (very dissatisfied).
Measured: 12- & 24-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Sep 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banff Sport Medicine Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation, CONMED Corporation
- Responsible party
- Sponsor
- Investigators
- Laurie A Hiemstra, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759039
- Sponsor's protocol ID
- REB17-1256
- Acronym
- SHYFT
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Pilot Trial Comparing Isolated Medial Patellofemoral Ligament Reconstruction to Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tubercle Osteotomy: SHould You TransFer the Tubercle (SHYFT)?
- ClinicalTrials.gov ID
- NCT05759039
- Acronym / sponsor ID
- SHYFT / REB17-1256
- Conditions
- Patellofemoral Dislocation, Tibial Tubercle Osteotomy, Medial Patellofemoral Ligament Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Banff Sport Medicine FoundationUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Foundation, CONMED Corporation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Mar 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.
The aim of this study is to investigate the role of tibial tubercle osteotomy (TTO) on the subjective and objective outcomes following medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance with or without patella alta.
This Pilot RCT will assess the feasibility of conducting this study for:
- The ability to recruit study patients
- Adherence to the study protocol
- Completion rates of patient follow-up at a minimum of 12 months post-operative
Detailed description
For patients with recurrent lateral patellofemoral instability, a medial patellofemoral ligament reconstruction (MPFL-R) consistently provides significant improvements in symptoms, quality of life, and return to sport. During an MPFL-R the surgeon will place a soft tissue graft from the medial patella to the femur. The graft used to create the new MPFL can be autograft (usually hamstring tendon) or allograft.
The tibial tubercle osteotomy (TTO) is a procedure designed to change the vector of the pull of the quadricep muscles by moving the insertion point of the patellar tendon. This is achieved by transferring the tendon with a block of bone to allow for consistent and reliable healing. The TTO is a versatile procedure that can move the patellar tendon insertion medially, anteriorly, or distally, or a combination of these directions. It can be used to correct a lateralized tibial tubercle or patella alta.
Despite the association of an increased TT-TG distance with patellofemoral instability, it has been difficult to demonstrate a correlation with patient outcomes after patellar stabilisation surgery. In addition, studies have been unable to correlate the pre-operative presence of patella alta with clinical outcomes after MPFL-R.
This randomized clinical pilot trial will randomly allocate patients with lateral patellofemoral instability and an elevated TT-TG distance with or without patella alta ato receive either an isolated MPFL-R or an MPFL-R in combination with a correcting TTO (medializing, distalizing, or a combination of both).
Patients will be followed for two years post-operative with subjective outcome measures and objective clinical and functional testing.
The study groups will be:
- Isolated MPFL-R
- MPFL-R with a TTO
The primary outcome measures will be:
- Number of study patients recruited
- Adherence to the study protocol (number of protocol deviations)
- Follow-up completion rates of study patients at a minimum of 12 months post-operative
Secondary outcome measures include the Banff Patellar Instability Instrument 2.0 (BPII 2.0), functional testing, clinical assessment, complications, re-dislocation rate, post-operative pain scores, patient satisfaction, and patient-reported outcome scores.
If feasibility is demonstrated via this Pilot RCT, a larger RCT will be designed to answer important questions on how to optimize outcomes and limit morbidity after MPFL-R.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFL-R | Active comparator | Procedure: Medial patellofemoral ligament reconstructionMedial patellofemoral ligament reconstruction |
| MPFL-R + TTO | Active comparator | Procedure: Medial patellofemoral ligament reconstruction, Procedure: Tibial tubercle osteotomyMedial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-30 years
- Symptomatic recurrent lateral patellofemoral instability
- TT-TG ≥15mm measured on MRI or ≥18mm on CT scan
- Closed physes (confirmed on knee x-rays)
Key exclusion criteria (8 listed)
- Caton-Deschamps ratio ≥ 1.4 on lateral radiographs
- Femoral anteversion ≥ 25 degrees on diagnostic imaging rotational profile
- Tibial external rotation ≥ 45 degrees on diagnostic imaging rotational profile
- High-grade trochlear dysplasia requiring trochleoplasty
- Significant osteoarthritis on skyline plain imaging (Kellgren Lawrence grade ≥ 2)
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 |
|---|---|---|
| Medial patellofemoral ligament reconstructionMedial patellofemoral ligament reconstruction | Procedure or surgery | MPFL-R, MPFL-R + TTO |
| Tibial tubercle osteotomyTibial tubercle osteotomy | Procedure or surgery | MPFL-R + TTO |
Primary outcome
Study Feasibility - patient recruitment
Time frame: 12-months post-operative
Number of study patients recruited
Study Feasibility - protocol adherence
Time frame: 12-months post-operative
Adherence to the study protocol (total number of protocol deviations)
Study Feasibility - follow-up completion
Time frame: 12-months post-operative
Number of patients completing follow-up a minimum of 12 months post-operative
6 secondary outcomes
Banff Patellofemoral Instability Instrument (BPII 2.0)
Time frame: Baseline, and 6-,12- & 24-months post-operative
Functional Outcomes - Hop Testing
Time frame: 6-, 12- & 24-months post-operative
Patellar Apprehension Test
Time frame: 6-, 12- & 24-months post-operative
Complications
Time frame: 6-, 12- & 24-months post-operative
Post-operative Knee Pain
Time frame: 6-, 12- & 24-months post-operative
Patient satisfaction
Time frame: 12- & 24-months post-operative
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 4 Feb 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
Biologic Augment of the Medial Patellofemoral Ligament Following Primary Lateral Patellofemoral Dislocation (BioPPD)
Patellofemoral Dislocation
Active, not recruiting
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
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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.
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 Medial patellofemoral ligament reconstruction and Tibial tubercle osteotomy in people with Patellofemoral Dislocation and Tibial Tubercle Osteotomy, 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 4 inclusion and 8 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 4 Feb 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. 6, hiemstra@banffsportmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility - patient recruitment (time frame: 12-months post-operative). The study lists 3 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 4 Feb 2025.