Recruiting

Observational Study

Sponsor:

Banff Sport Medicine Foundation

Code:

NCT05759039

Conditions

Patellofemoral Dislocation

Tibial Tubercle Osteotomy

Medial Patellofemoral Ligament Reconstruction

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

Interventions

Medial patellofemoral ligament reconstruction

Tibial tubercle osteotomy

Study Details

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

Conditions

Patellofemoral Dislocation

Tibial Tubercle Osteotomy

Medial Patellofemoral Ligament Reconstruction

Study ID

NCT05759039

Start date

Sep 1, 2023

Status verified date

Jan, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: MPFL-R

Medial patellofemoral ligament reconstruction

active comparator: MPFL-R + TTO

Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy

Interventions

Medial patellofemoral ligament reconstruction

Medial patellofemoral ligament reconstruction

Tibial tubercle osteotomy

Tibial tubercle osteotomy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Laurie A Hiemstra, MD, PhD

403 760 2897hiemstra@banffsportmed.ca

Sarah Kerslake, BPhty

403 760 2897sarah@banffsportmed.ca

Locations

Banff Sport Medicine

Recruiting

Canmore, Alberta, Canada, T1W 0L5

Contacts

Laurie Hiemstra, MD PhD FRCSC

4037602897

More Information

Sponsor

Banff Sport Medicine Foundation

Last update posted

Feb 4, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Banff Sport Medicine Foundation on 2025-02-04.