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Rotator Cuff InjuriesIMPACTNCT05444465

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

A study testing Isolated Bioinductive Repair and Completion and Repair in people with Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 20 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rotator Cuff Injuries
What is being tested?
Isolated Bioinductive Repair and Completion and Repair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
20 sitesin 6 countries
Study dates
30 Aug 2022to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)).
Show all 27Show fewer
  • 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.

Trial locations and contacts

20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Judith Horner contact

+44 (0) 7834614336

judith.horner@smith-nephew.com

Mary Ozokwere contact

+1 469-560-0727

Mary.Ozokwere@smith-nephew.com

20 sites in 6 countries

United States8 sites, 3 recruiting

  • Memorial Medical Center

    Ashland, Wisconsin, 54806

    Withdrawn

  • Sinai Hospital Baltimore

    Baltimore, Maryland, 21215

    Withdrawn

  • Texas Orthopedic Specialists

    Bedford, Texas, 76021

    Active, not recruiting

  • Cleveland Clinic - Sports Health

    Garfield Heights, Ohio, 44125

    Withdrawn

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Alec Howard

    Albert Lin

    Recruiting

  • OrthoIllinois LTD

    Rockford, Illinois, 61107

    Catherine Ayala

    Scott Trenhaile

    Recruiting

  • Harbin Clinic

    Rome, Georgia, 30165

    Terri Brannon

    Brandon Bushnell

    Recruiting

  • Houston Methodist The Woodlands

    The Woodlands, Texas, 77385

    Withdrawn

Other trials in United States

United Kingdom4 sites, 3 recruiting

  • Sulis Hospital

    Bath

    Andrew Chambler

    Recruiting

  • North Bristol NHS Trust

    Bristol

    Steven Barnfield

    Iain Packham

    Recruiting

  • Ashford & St Peter's Hospitals NHS Foundation Trust

    Chertsey, Surrey, KT16 0PZ

    Timnit Tekie

    Ali Narvani

    Recruiting

  • Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD

    Withdrawn

Other trials in United Kingdom

Canada3 sites, 2 recruiting

  • Access Orthopaedics

    Calgary, Alberta, T2R 2G5

    Kristie More

    Ian Lo

    Recruiting

  • Research St. Joseph's

    Hamilton, Ontario

    Danielle Dagher

    Moin Khan

    Recruiting

  • Pan Am Clinic

    Winnipeg, Manitoba

    Active, not recruiting

Other trials in Canada

Italy2 sites, 2 recruiting

  • IRCCS Istituto Ortopedico Galeazzi,

    Milan

    Vincenzo Guarrella

    Ettore Taverna

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma

    Giuseppe Longo

    Giuseppe Longo

    Recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

  • Hospital Ramón y Cajal

    Madrid, 28034

    Miguel Angel Ruiz Iban

    Miguel Angel Ruiz Iban

    Recruiting

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040

    Cristina Delgado del Cano

    Emilio Calvo

    Recruiting

Other trials in Spain

Australia1 site, 1 recruiting

  • OrthoSport Victoria

    Richmond, Victoria, 3121

    Haydn Klemm

    Soong Chua

    Recruiting

Other trials in Australia

About this study

Official title: Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

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.

Read the detailed description

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).

Being tested
Isolated Bioinductive Repair, Completion and Repair
Keywords
Rotator cuff tear, High grade partial thickness tears, REGENETEN Bioinductive Implant System
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isolated Bioinductive RepairDevice

    Also called REGENETEN™ Bioinductive Implant

    Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

  • Completion and RepairProcedure or surgery

    Standard surgical repair using the 'Completion and Repair' technique.

Study groups in NCT05444465
Study groupRoleWhat they receive
Isolated Bioinductive RepairExperimentalSurgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Receives: Device: Isolated Bioinductive Repair
Completion and RepairActive comparatorSurgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
Receives: Procedure: Completion and Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change from baseline to 3 months post-intervention

Secondary outcomes (25)

  1. 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).

    Measured: Pre-op, 6 weeks, 3, 6, 12 and 24 months

  2. Constant-Murley Score

    The 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.

    Measured: Pre-Op, 3, 6, 12 and 24 months

  3. Subjective Shoulder Value (SSV) score

    The 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).

    Measured: Pre-Op, 6 weeks, 3, 12 and 24 months

  4. EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores

    To 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.

    Measured: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months

  5. 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).

    Measured: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months

  6. Change in Constant-Murley Score

    The 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.

    Measured: Change from Pre-Op to 6 weeks, 3, 12 and 24 months

  7. Change in Subjective Shoulder Value (SSV) score

    The 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).

    Measured: Change from Pre-Op to 6 weeks, 3, 12 and 24 months

  8. Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score

    The 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.

    Measured: Pre-Op, 3, 6, 12 and 24 months

  9. 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).

    Measured: Pre-op, 6 weeks, 3, 6, 12 and 24 months

  10. Percent Achieving MCID for Subjective Shoulder Value (SSV) score

    The 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).

    Measured: Pre-Op, 6 weeks, 3, 12 and 24 months

  11. Patient Satisfaction

    Comprise 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.

    Measured: 6 weeks, 3, 6, 12 and 24 months

  12. Pain, Visual analog scale (VAS) Score

    Pain 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.

    Measured: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months

  13. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score

    The 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.

    Measured: 12 months

  14. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling

    Percent 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%.

    Measured: 12 months

  15. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern

    The 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.

    Measured: 12 months

  16. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness

    Tendon thickness will be measured in millimeters (mm).

    Measured: 12 months

  17. MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification

    The 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.

    Measured: 12 months

  18. Incidence of Revision Surgery

    Number of subjects requiring revision surgery

    Measured: 1, 3 and 6 weeks, 3, 6, 12 and 24 months

  19. Time to return to work

    Number of weeks taken to return to work following surgery

    Measured: Up to 24 months

  20. Time to return to driving

    Number of weeks taken to return to driving following surgery

    Measured: Up to 24 months

  21. Time to return to sports

    Number of weeks taken to return to sport following surgery

    Measured: Up to 24 months

  22. Total operative time

    Time expressed in minutes

    Measured: Inter-operative time

  23. Physical Therapy Utilization

    Number visits following index surgery

    Measured: Up to 24 months

  24. Cumulative days of opioid use

    Self-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?'

    Measured: Day 1-14

  25. Duration of shoulder immobilization following index surgery

    Number of days

    Measured: 1, 3 and 6 weeks, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start30 Aug 2022
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444465
Sponsor's protocol ID
REGENETEN.2021.04
Acronym
IMPACT
Status last verified
Sep 2026
First submitted
29 Jun 2022
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Isolated Bioinductive Repair and Completion and Repair in people with Rotator Cuff Injuries, run by Smith & Nephew, Inc. at 20 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, United Kingdom, Canada, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Judith Horner (+44 (0) 7834614336, judith.horner@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Western Ontario Rotator Cuff (WORC) (time frame: Change from baseline to 3 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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