Share

Save

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

RECRUITING

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

info
Simpliy with AI

Study details:

The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • The subject must provide written informed consent.
  • Subject is > eighteen (18) years of age (no upper limit).
  • Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
  • Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
  • Subject willing and able to make all required study visits.
  • Subject able to follow instructions and deemed capable of completing all study questionnaires.
  • Exclusion criteria

  • Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
  • Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
  • Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
  • Subjects with current or prior infection of the ipsilateral shoulder.
  • Subjects with known hypersensitivity to bovine-derived materials.
  • Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
  • Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
  • Subjects with a planned surgery on the contra-lateral shoulder within the study period.
  • Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
  • Subjects with a full thickness rotator cuff tear.
  • Subjects with a subscapularis tear requiring repair.
  • Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
  • Subjects requiring a concomitant os acromiale fixation procedure.
  • Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
  • Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
  • Subjects with neurologic conditions effecting either upper extremity.
  • Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
  • Subjects who are pregnant or breast feeding.
  • Subjects who are currently involved in any injury litigation relating to the index shoulder.
  • Subjects with current workers compensation claim.
  • Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
  • Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
  • Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
  • Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
  • Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
  • Subjects who have participated previously in this clinical trial and who have healed or been withdrawn.
  • Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
  • info
    Simplify with AI

    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-08-30

    Primary completion: 2025-09-30

    Study completion finish: 2027-06-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05444465

    Intervention or treatment

    DEVICE: Isolated Bioinductive Repair

    PROCEDURE: Completion and Repair

    Conditions

    • Rotator Cuff Injuries

    Find a site

    Closest Location:

    OrthoSport Victoria

    Research sites nearby

    Select from list below to view details:

    • OrthoSport Victoria

      Richmond, Victoria, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Isolated Bioinductive Repair
    • Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
    DEVICE: Isolated Bioinductive Repair
    • Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
    ACTIVE_COMPARATOR: Completion and Repair
    • Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
    PROCEDURE: Completion and Repair
    • Standard surgical repair using the 'Completion and Repair' technique.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in Western Ontario Rotator Cuff (WORC)The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).Change from baseline to 3 months post-intervention

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Western Ontario Rotator Cuff (WORC)The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).Pre-op, 6 weeks, 3, 6, 12 and 24 months
    Constant-Murley ScoreThe Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.Pre-Op, 3, 6, 12 and 24 months
    Subjective Shoulder Value (SSV) scoreThe SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).Pre-Op, 6 weeks, 3, 12 and 24 months
    EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scoresTo assess the subject's health state. The EQ-5D-5L is composed of the EQ- 5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ- 5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
    Change in Western Ontario Rotator Cuff (WORC)The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
    Change in Constant-Murley ScoreThe Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.Change from Pre-Op to 6 weeks, 3, 12 and 24 months
    Change in Subjective Shoulder Value (SSV) scoreThe SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).Change from Pre-Op to 6 weeks, 3, 12 and 24 months
    Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley ScoreThe Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.Pre-Op, 3, 6, 12 and 24 months
    Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).Pre-op, 6 weeks, 3, 6, 12 and 24 months
    Percent Achieving MCID for Subjective Shoulder Value (SSV) scoreThe SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).Pre-Op, 6 weeks, 3, 12 and 24 months
    Patient SatisfactionComprise of 2 questions: 1. Overall, I am satisfied with the outcome of my surgery 2. I would recommend the procedure to a friend. Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.6 weeks, 3, 6, 12 and 24 months
    Pain, Visual analog scale (VAS) ScorePain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable.Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
    MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya ScoreThe Sugaya score is classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.12 months
    MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent fillingPercent tissue infil is graded at site of original tear and classified as 0% to \< 25%, 25% to \< 50%, 50% to \< 75%, 75% to \< 100% and 100%.12 months
    MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity patternThe Signal Intensity Pattern will be graded into 3 categories. Type I: Heterogeneous high signal intensity with fluid-like bright foci, Type II: Heterogeneous high signal intensity without fluid-like bright foci, Type III: Heterogeneous or homogeneous low signal intensity.12 months
    MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thicknessTendon thickness will be measured in millimeters (mm).12 months
    MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classificationThe Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present.12 months
    Incidence of Revision SurgeryNumber of subjects requiring revision surgery1, 3 and 6 weeks, 3, 6, 12 and 24 months
    Time to return to workNumber of weeks taken to return to work following surgeryUp to 24 months
    Time to return to drivingNumber of weeks taken to return to driving following surgeryUp to 24 months
    Time to return to sportsNumber of weeks taken to return to sport following surgeryUp to 24 months
    Total operative timeTime expressed in minutesInter-operative time
    Physical Therapy UtilizationNumber visits following index surgeryUp to 24 months
    Cumulative days of opioid useSelf-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?'Day 1-14
    Duration of shoulder immobilization following index surgeryNumber of days1, 3 and 6 weeks, 3 months

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

    Other trails to consider

    Top searched conditions