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Recruiting NCT05759039

SHould You TransFer the Tubercle?

No phase Interventional Patellofemoral Dislocation Tibial Tubercle Osteotomy Medial Patellofemoral Ligament Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial patellofemoral ligament reconstruction, Tibial tubercle osteotomy.
Who it may be relevant to
Registry conditions: Patellofemoral Dislocation, Tibial Tubercle Osteotomy, Medial Patellofemoral Ligament Reconstruction. Basic parameters: 13 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)?

Overview

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.

Interventions

  • Procedure Medial patellofemoral ligament reconstruction
    Medial patellofemoral ligament reconstruction
  • Procedure Tibial tubercle osteotomy
    Tibial tubercle osteotomy

Primary outcome measures

  • Study Feasibility - patient recruitment [Time frame: 12-months post-operative]
  • Study Feasibility - protocol adherence [Time frame: 12-months post-operative]
  • Study Feasibility - follow-up completion [Time frame: 12-months post-operative]
Secondary outcome measures (6)
  • Banff Patellofemoral Instability Instrument (BPII 2.0) [Time frame: Baseline, and 6-,12- & 24-months post-operative]
  • Functional Outcomes - Hop Testing [Time frame: 6-, 12- & 24-months post-operative]
  • Patellar Apprehension Test [Time frame: 6-, 12- & 24-months post-operative]
  • Complications [Time frame: 6-, 12- & 24-months post-operative]
  • Post-operative Knee Pain [Time frame: 6-, 12- & 24-months post-operative]
  • Patient satisfaction [Time frame: 12- & 24-months post-operative]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Banff Sport Medicine — Canmore

Identifiers

NCT: NCT05759039 · REB17-1256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗