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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05759039
Other study ID # REB17-1256
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2026

Study information

Verified date December 2023
Source Banff Sport Medicine Foundation
Contact Laurie A Hiemstra, MD, PhD
Phone 403 760 2897
Email hiemstra@banffsportmed.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 1, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years to 30 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Medial patellofemoral ligament reconstruction
Medial patellofemoral ligament reconstruction

Locations

Country Name City State
Canada Banff Sport Medicine Canmore Alberta

Sponsors (3)

Lead Sponsor Collaborator
Banff Sport Medicine Foundation Canadian Orthopaedic Foundation, CONMED Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study Feasibility - patient recruitment Number of study patients recruited 12-months post-operative
Primary Study Feasibility - protocol adherence Adherence to the study protocol (total number of protocol deviations) 12-months post-operative
Primary Study Feasibility - follow-up completion Number of patients completing follow-up a minimum of 12 months post-operative 12-months post-operative
Secondary 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. Baseline, and 6-,12- & 24-months post-operative
Secondary Functional Outcomes - Hop Testing Limb Symmetry Index on 4 single-leg hop test battery (assessed as percentage score operative / non-operative limb) 6-, 12- & 24-months post-operative
Secondary Patellar Apprehension Test Rate of positive patellar apprehension 6-, 12- & 24-months post-operative
Secondary Complications Rate of post-operative complications including infection, blood clots, reduced range of motion, persistent pain, persistent swelling, and re-dislocations 6-, 12- & 24-months post-operative
Secondary Post-operative Knee Pain Post-operative pain score measured on a 10-point visual analogue scale 6-, 12- & 24-months post-operative
Secondary Patient satisfaction Measured on a 5-point Likert scale 6-, 12- & 24-months post-operative
See also
  Status Clinical Trial Phase
Completed NCT04143438 - Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics N/A
Not yet recruiting NCT06169800 - Biologic Augment of the Medial Patellofemoral Ligament Following Primary Lateral Patellofemoral Dislocation (BioPPD) N/A
Completed NCT04242732 - Patellar Stability After MPFL Reconstruction With Fascia Lata Allograft: Conventional CT vs Under Weight-bearing CT N/A
Recruiting NCT04243265 - Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction N/A