Banff Sport Medicine
Canmore, Alberta, T1W 0L5, Canada
Location status: Recruiting
NCT Number: NCT05759039
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:
1. The ability to recruit study patients 2. Adherence to the study protocol 3. Completion rates of patient follow-up at a minimum of 12 months post-operative
Interested in participating?
Request Info13 year–30 year
All sexes
Interventional
Not applicable
Canmore, Alberta, T1W 0L5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medial patellofemoral ligament reconstruction
Tibial tubercle osteotomy
Time frame: 12-months post-operative
Number of study patients recruited
Time frame: 12-months post-operative
Adherence to the study protocol (total number of protocol deviations)
Time frame: 12-months post-operative
Number of patients completing follow-up a minimum of 12 months post-operative
Time frame: Baseline, and 6-,12- & 24-months post-operative
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.
Time frame: 6-, 12- & 24-months post-operative
Limb Symmetry Index on 4 single-leg hop test battery (assessed as percentage score operative / non-operative limb)
Time frame: 6-, 12- & 24-months post-operative
Rate of positive patellar apprehension
Time frame: 6-, 12- & 24-months post-operative
Rate of post-operative complications including infection, blood clots, reduced range of motion, persistent pain, persistent swelling, and re-dislocations
Time frame: 6-, 12- & 24-months post-operative
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".
Time frame: 12- & 24-months post-operative
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).
Contact information is provided by the study sponsor or research team.
Laurie A Hiemstra, MD, PhD
CONTACT
403 760 2897 ext. 6
Sarah Kerslake, BPhty
CONTACT
403 760 2897 ext. 6
Banff Sport Medicine Foundation
Other
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)?
Acronym: SHYFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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