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Medial Patellofemoral Ligament Reconstruction for Knee Dislocation (SHYFT Trial)

N/A
Recruiting
Led By Laurie A Hiemstra, MD, PhD
Research Sponsored by Banff Sport Medicine Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-, 12- & 24-months post-operative
Awards & highlights

SHYFT Trial Summary

This trial will study the effect of an operation (TTO) on the knee (MPFL-R) to improve outcomes in people with an increased distance between the knee bones.

Who is the study for?
This trial is for young people aged 13-30 with recurrent knee cap dislocation and specific bone alignment issues (TT-TG ≥15mm on MRI or ≥18mm on CT). They must have mature bones, confirmed by x-rays. It's not for those with certain knee ratios, excessive femoral or tibial rotation, severe groove deformities needing surgery, advanced arthritis in the kneecap joint, cartilage restoration procedures, inability to do computer questionnaires or if pregnant.Check my eligibility
What is being tested?
The study tests whether adding a bone realignment procedure (tibial tubercle osteotomy) to a ligament reconstruction surgery improves outcomes in patients with misaligned knees causing instability. This pilot randomized controlled trial will check how feasible it is to recruit participants and follow them up at least one year after surgery.See study design
What are the potential side effects?
Potential side effects may include pain at the surgical site, swelling, infection risk post-surgery, complications from anesthesia during operation and possible need for additional surgeries if there are issues with healing or alignment.

SHYFT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-, 12- & 24-months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-, 12- & 24-months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study Feasibility - follow-up completion
Study Feasibility - patient recruitment
Study Feasibility - protocol adherence
Secondary outcome measures
Banff Patellofemoral Instability Instrument (BPII 2.0)
Complications
Functional Outcomes - Hop Testing
+3 more

SHYFT Trial Design

2Treatment groups
Active Control
Group I: MPFL-RActive Control1 Intervention
Medial patellofemoral ligament reconstruction
Group II: MPFL-R + TTOActive Control1 Intervention
Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy

Find a Location

Who is running the clinical trial?

ConMed CorporationIndustry Sponsor
8 Previous Clinical Trials
771 Total Patients Enrolled
CONMED CorporationIndustry Sponsor
10 Previous Clinical Trials
1,059 Total Patients Enrolled
1 Trials studying Patellofemoral Dislocation
20 Patients Enrolled for Patellofemoral Dislocation
Banff Sport Medicine FoundationLead Sponsor
3 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Patellofemoral Dislocation
20 Patients Enrolled for Patellofemoral Dislocation

Media Library

Medial patellofemoral ligament reconstruction Clinical Trial Eligibility Overview. Trial Name: NCT05759039 — N/A
Patellofemoral Dislocation Research Study Groups: MPFL-R, MPFL-R + TTO
Patellofemoral Dislocation Clinical Trial 2023: Medial patellofemoral ligament reconstruction Highlights & Side Effects. Trial Name: NCT05759039 — N/A
Medial patellofemoral ligament reconstruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05759039 — N/A
~20 spots leftby Dec 2025
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