Health TrialsbyHealthPanel

SHould You TransFer the Tubercle?

ConditionsPatellofemoral DislocationTibial Tubercle OsteotomyMedial Patellofemoral Ligament Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-30
SponsorBanff Sport Medicine Foundation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medial patellofemoral ligament reconstruction

    Procedure/Surgery

    Medial patellofemoral ligament reconstruction

  • Tibial tubercle osteotomy

    Procedure/Surgery

    Tibial tubercle osteotomy

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: MPFL-RActive comparator 1 intervention
Group B: MPFL-R + TTOActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Study Feasibility - patient recruitment

Number of study patients recruited

Time frame
12-months post-operative
2

Study Feasibility - protocol adherence

Adherence to the study protocol (total number of protocol deviations)

Time frame
12-months post-operative
3

Study Feasibility - follow-up completion

Number of patients completing follow-up a minimum of 12 months post-operative

Time frame
12-months post-operative

Secondary outcomes

1

Banff Patellofemoral Instability Instrument (BPII 2.0)

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
Baseline, and 6-,12- & 24-months post-operative
2

Functional Outcomes - Hop Testing

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
3

Patellar Apprehension Test

Rate of positive patellar apprehension

Time frame
6-, 12- & 24-months post-operative
4

Complications

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Banff Sport Medicine Foundation

Lead sponsor

Canadian Orthopaedic Foundation

Collaborator

CONMED Corporation

Collaborator

Source ClinicalTrials.gov
Apply now