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NCT Number: NCT05759039

SHould You TransFer the Tubercle?

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

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Key information

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banff Sport Medicine

Canmore, Alberta, T1W 0L5, Canada

Location status: Recruiting

Location contact

Laurie Hiemstra, MD PhD FRCSC

CONTACT

4037602897

About this study

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:

  • Isolated MPFL-R
  • MPFL-R with a TTO

The primary outcome measures will be:

  • Number of study patients recruited
  • Adherence to the study protocol (number of protocol deviations)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medial patellofemoral ligament reconstruction

Procedure

Medial patellofemoral ligament reconstruction

Tibial tubercle osteotomy

Procedure

Tibial tubercle osteotomy

Primary outcomes

  1. Study Feasibility - patient recruitment

    Time frame: 12-months post-operative

    Number of study patients recruited

  2. Study Feasibility - protocol adherence

    Time frame: 12-months post-operative

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

  3. Study Feasibility - follow-up completion

    Time frame: 12-months post-operative

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

Secondary outcomes

  1. Banff Patellofemoral Instability Instrument (BPII 2.0)

    Time frame: Baseline, and 6-,12- & 24-months post-operative

    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.

  2. Functional Outcomes - Hop Testing

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

    Limb Symmetry Index on 4 single-leg hop test battery (assessed as percentage score operative / non-operative limb)

  3. Patellar Apprehension Test

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

    Rate of positive patellar apprehension

  4. Complications

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

    Rate of post-operative complications including infection, blood clots, reduced range of motion, persistent pain, persistent swelling, and re-dislocations

  5. Post-operative Knee Pain

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

    Post-operative pain score measured on a 10-point visual analogue scale

    The Pain VAS is anchored by 0, which corresponds to "no pain", and 10, which corresponds to the "worst possible pain".

  6. Patient satisfaction

    Time frame: 12- & 24-months post-operative

    Measured on a 5-point Likert scale

    A 5-point patient satisfaction scale measures patient happiness with healthcare services, ranging from 5 (very satisfied) to 1 (very dissatisfied).

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie A Hiemstra, MD, PhD

CONTACT

[email protected]

403 760 2897 ext. 6

Sarah Kerslake, BPhty

CONTACT

[email protected]

403 760 2897 ext. 6

Sponsors and collaborators

Lead sponsor

Banff Sport Medicine Foundation

Other

Collaborators

  • CONMED Corporation
  • Canadian Orthopaedic Foundation

Registry information

Official study title

A Randomized Clinical Pilot Trial Comparing Isolated Medial Patellofemoral Ligament Reconstruction to Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tubercle Osteotomy: SHould You TransFer the Tubercle (SHYFT)?

Acronym: SHYFT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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