SHould You transFer the Tubercle? — SHYFT  

Patellofemoral Dislocation Clinical Trial

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)?

Status Recruiting

Clinical 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.

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

Clinical Trial 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:

1. Isolated MPFL-R

2. MPFL-R with a TTO

The primary outcome measures will be:

1. Number of study patients recruited

2. Adherence to the study protocol (number of protocol deviations)

3. 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. ;

Related Conditions & MeSH terms

• Medial Patellofemoral Ligament Reconstruction
• Patellofemoral Dislocation
• Tibial Tubercle Osteotomy

• NCT number: NCT05759039
• Study type: Interventional
• Source: Banff Sport Medicine Foundation
• Contact: Laurie A Hiemstra, MD, PhD
• Phone: 403 760 2897
• Email: hiemstra@banffsportmed.ca
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: September 1, 2026