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NCT Number: NCT05959733

Maximal Repair Versus Bridging Reconstruction with BioBrace®

The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.

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Key information

Conditions

Rotator Cuff Tears Bioinductive Implant Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E1, Canada

Location status: Recruiting

Location contact

Ivan Wong

CONTACT

[email protected]

9024737626

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
  • over 18 years of age

Exclusion criteria

  • glenohumeral osteoarthritis
  • Western Ontario rotator cuff score >60
  • uncontrolled diabetes (Hgb A1C >7%)
  • pregnant
  • local or systemic infection
  • inability to cooperate with and/or comprehend post-operative instructions
  • MRI proven non-vascular sites
  • poor nutritional state (Alb <30 g/L)
  • cancer
  • paralysis of the shoulder
  • contracture of the shoulder
  • patients unable to provide informed consent for the study

Treatment and study plan

Bridging Reconstruction using BioBrace

Procedure

Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.

Repair

Procedure

Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.

Primary outcomes

  1. Radiographic or clinical failure

    Time frame: 2 years

    The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up

Secondary outcomes

  1. Acromiohumeral Distance

    Time frame: 2 year

    Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.

  2. Muscle Atrophy

    Time frame: 2 year

    Using MRI, muscle atrophy will be measured using Warner's classification between groups.

  3. Fatty Infiltration

    Time frame: 2 year

    Fatty infiltration using the Goutallier classification will be used and identified

  4. Healing Rate

    Time frame: 2 year

    To measure the structural integrity of the surgery, Sugaya method will be used.

  5. Western Ontario Rotator Cuff Index (WORC)

    Time frame: Baseline, 6-month, 1-year, 2-years

    WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years

  6. American Shoulder and Elbow Surgeon survey

    Time frame: Baseline, 6-month, 1-year, 2-years

    American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years

  7. EQ-5D-5L

    Time frame: Baseline, 6-month, 1-year, 2-years

    EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years

  8. Range of motion

    Time frame: Baseline, 6-month, 1-year, 2-years

    The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years

  9. Shoulder strength

    Time frame: Baseline, 6-month, 1-year, 2-years

    The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years

  10. Biomechanics and Muscle Activity

    Time frame: Baseline and 2 years

    Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment.

Study contacts

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

Sarah Remedios, MSc

CONTACT

[email protected]

9024737626

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • CONMED Corporation

Registry information

Official study title

Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2023
Registry last updated
Feb 18, 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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