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)?

What this Trial Is About

Researchers are evaluating the role of tibial tubercle osteotomy (TTO) in improving outcomes after medial patellofemoral ligament reconstruction (MPFL-R) in patients who have recurrent lateral patellofemoral instability with an increased tibial tubercle-trochlear groove (TT-TG) distance, with or without patella alta. This pilot randomized clinical trial aims to assess the feasibility of recruitment, adherence to the study protocol, and follow-up completion rates over at least 12 months. The study is conducted by the Banff Sport Medicine Foundation and focuses on patients aged 13 to 30 years. Participants will be randomly assigned to one of two groups: isolated MPFL-R or MPFL-R combined with TTO, which can involve medializing, distalizing, or combined adjustments of the patellar tendon insertion. The MPFL-R involves placing a soft tissue graft, either autograft or allograft, to stabilize the patella. The TTO procedure moves the insertion point of the patellar tendon by transferring a bone block to correct the patella's position. Patients will be followed for two years after surgery. During the study, participants will undergo subjective and objective assessments at baseline and at 6, 12, and 24 months post-operation. These include the Banff Patellofemoral Instability Instrument (BPII 2.0), functional hop testing, patellar apprehension tests, pain scores, patient satisfaction, and clinical evaluations. Researchers will monitor complications and re-dislocation rates. The primary feasibility outcomes focus on recruitment, protocol adherence, and follow-up completion at 12 months. The study aims to inform a larger trial to optimize treatment for patellofemoral instability.

SHould You TransFer the Tubercle?