NCT05759039

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. 1.The ability to recruit study patients
  2. 2.Adherence to the study protocol
  3. 3.Completion rates of patient follow-up at a minimum of 12 months post-operative

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

February 17, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

February 17, 2023

Last Update Submit

January 31, 2025

Conditions

Patellofemoral DislocationTibial Tubercle OsteotomyMedial Patellofemoral Ligament Reconstruction

Outcome Measures

Primary Outcomes (3)

  • Study Feasibility - patient recruitment

    Number of study patients recruited

    12-months post-operative

  • Study Feasibility - protocol adherence

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

    12-months post-operative

  • Study Feasibility - follow-up completion

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

    12-months post-operative

Secondary Outcomes (6)

  • Banff Patellofemoral Instability Instrument (BPII 2.0)

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

  • Functional Outcomes - Hop Testing

    6-, 12- & 24-months post-operative

  • Patellar Apprehension Test

    6-, 12- & 24-months post-operative

  • Complications

    6-, 12- & 24-months post-operative

  • Post-operative Knee Pain

    6-, 12- & 24-months post-operative

  • +1 more secondary outcomes

Study Arms (2)

MPFL-R

ACTIVE COMPARATOR

Medial patellofemoral ligament reconstruction

Procedure: Medial patellofemoral ligament reconstruction

MPFL-R + TTO

ACTIVE COMPARATOR

Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy

Procedure: Medial patellofemoral ligament reconstructionProcedure: Tibial tubercle osteotomy

Interventions

Medial patellofemoral ligament reconstructionPROCEDURE

Medial patellofemoral ligament reconstruction

MPFL-RMPFL-R + TTO
Tibial tubercle osteotomyPROCEDURE

Tibial tubercle osteotomy

MPFL-R + TTO

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banff Sport Medicine

Canmore, Alberta, T1W 0L5, Canada

RECRUITING

Study Officials

  • Laurie A Hiemstra, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie A Hiemstra, MD, PhD

CONTACT

403 760 2897hiemstra@banffsportmed.ca

Sarah Kerslake, BPhty

CONTACT

403 760 2897sarah@banffsportmed.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 8, 2023

Study Start

September 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)