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| Name | Class |
|---|---|
| Canadian Orthopaedic Foundation | OTHER |
| CONMED Corporation | INDUSTRY |
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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:
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:
The primary outcome measures will be:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPFL-R | Active Comparator | Medial patellofemoral ligament reconstruction |
|
| MPFL-R + TTO | Active Comparator | Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial patellofemoral ligament reconstruction | Procedure | Medial patellofemoral ligament reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility - patient recruitment | Number of study patients recruited | 12-months post-operative |
| Study Feasibility - protocol adherence | Adherence to the study protocol (total number of protocol deviations) | 12-months post-operative |
| Study Feasibility - follow-up completion | Number of patients completing follow-up a minimum of 12 months post-operative | 12-months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, and 6-,12- & 24-months post-operative |
| Functional Outcomes - Hop Testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurie A Hiemstra, MD, PhD | Contact | 403 760 2897 | 6 | hiemstra@banffsportmed.ca |
| Sarah Kerslake, BPhty | Contact | 403 760 2897 | 6 | sarah@banffsportmed.ca |
| Name | Affiliation | Role |
|---|---|---|
| Laurie A Hiemstra, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banff Sport Medicine | Recruiting | Canmore | Alberta | T1W 0L5 | Canada |
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| Tibial tubercle osteotomy | Procedure | Tibial tubercle osteotomy |
|
Limb Symmetry Index on 4 single-leg hop test battery (assessed as percentage score operative / non-operative limb) |
| 6-, 12- & 24-months post-operative |
| Patellar Apprehension Test | Rate of positive patellar apprehension | 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 | 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". | 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). | 12- & 24-months post-operative |