SHould You TransFer the Tubercle?

NCT ID: NCT05759039

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-09-01

Brief 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

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:

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.

Conditions

Patellofemoral Dislocation; Tibial Tubercle Osteotomy; Medial Patellofemoral Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MPFL-R

Medial patellofemoral ligament reconstruction

Group Type: ACTIVE_COMPARATOR

Medial patellofemoral ligament reconstruction

Intervention Type: PROCEDURE

Medial patellofemoral ligament reconstruction

MPFL-R + TTO

Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy

Group Type: ACTIVE_COMPARATOR

Medial patellofemoral ligament reconstruction

Intervention Type: PROCEDURE

Medial patellofemoral ligament reconstruction

Tibial tubercle osteotomy

Intervention Type: PROCEDURE

Tibial tubercle osteotomy

Interventions

Medial patellofemoral ligament reconstruction

Medial patellofemoral ligament reconstruction

Intervention Type: PROCEDURE

Tibial tubercle osteotomy

Tibial tubercle osteotomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Orthopaedic Foundation

OTHER

Sponsor Role: collaborator

CONMED Corporation

INDUSTRY

Sponsor Role: collaborator

Banff Sport Medicine Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie A Hiemstra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Banff Sport Medicine

Canmore, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laurie A Hiemstra, MD, PhD

Role: CONTACT

hiemstra@banffsportmed.ca

403 760 2897 ext. 6

Sarah Kerslake, BPhty

Role: CONTACT

sarah@banffsportmed.ca

403 760 2897 ext. 6

Facility Contacts

Laurie Hiemstra, MD PhD FRCSC

Role: primary

4037602897

Other Identifiers

REB17-1256

Identifier Type: -

Identifier Source: org_study_id