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Utilisation du système d'implant bioinductif REGENETEN™ dans les déchirures d'épaisseur partielle de haut grade (IMPACT)

23 septembre 2026 mis à jour par: Smith & Nephew, Inc.

Évaluation de l'innocuité et de l'efficacité d'un implant de collagène résorbable dans le traitement des déchirures d'épaisseur partielle de haut grade ; Un essai prospectif, multicentrique, randomisé et contrôlé (étude IMPACT)

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

234

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Australie
    • Victoria
      • Richmond, Victoria, Australie, 3121
        • Recrutement
        • OrthoSport Victoria
        • Chercheur principal:
          • Soong Chua
        • Contact:
          • Haydn Klemm
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 2G5
        • Recrutement
        • Access Orthopaedics
        • Contact:
          • Kristie More
        • Chercheur principal:
          • Ian Lo
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Actif, ne recrute pas
        • Pan Am Clinic
    • Ontario
      • Hamilton, Ontario, Canada
        • Recrutement
        • Research St. Joseph's
        • Chercheur principal:
          • Moin Khan
        • Contact:
          • Danielle Dagher
  • Espagne
      • Madrid, Espagne, 28034
        • Recrutement
        • Hospital Ramón y Cajal
        • Contact:
          • Miguel Angel Ruiz Iban
        • Chercheur principal:
          • Miguel Angel Ruiz Iban
      • Madrid, Espagne, 28040
        • Recrutement
        • Hospital Fundación Jiménez Díaz
        • Contact:
          • Cristina Delgado del Cano
        • Chercheur principal:
          • Emilio Calvo
  • Italie
      • Milan, Italie
        • Recrutement
        • IRCCS Istituto Ortopedico Galeazzi,
        • Contact:
          • Vincenzo Guarrella
        • Chercheur principal:
          • Ettore Taverna
      • Roma, Italie
        • Recrutement
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
          • Giuseppe Longo
        • Chercheur principal:
          • Giuseppe Longo
  • Royaume-Uni
      • Bath, Royaume-Uni
        • Recrutement
        • Sulis Hospital
        • Chercheur principal:
          • Andrew Chambler
      • Bristol, Royaume-Uni
        • Recrutement
        • North Bristol NHS Trust
        • Contact:
          • Steven Barnfield
        • Chercheur principal:
          • Iain Packham
      • Salford, Royaume-Uni, M6 8HD
        • Retiré
        • Northern Care Alliance NHS Foundation Trust
    • Surrey
      • Chertsey, Surrey, Royaume-Uni, KT16 0PZ
        • Recrutement
        • Ashford & St Peter's Hospitals NHS Foundation Trust
        • Chercheur principal:
          • Ali Narvani
        • Contact:
          • Timnit Tekie
  • États-Unis
    • Georgia
      • Rome, Georgia, États-Unis, 30165
        • Recrutement
        • Harbin Clinic
        • Chercheur principal:
          • Brandon Bushnell
        • Contact:
          • Terri Brannon
    • Illinois
      • Rockford, Illinois, États-Unis, 61107
        • Recrutement
        • OrthoIllinois LTD
        • Chercheur principal:
          • Scott Trenhaile
        • Contact:
          • Catherine Ayala
    • Maryland
      • Baltimore, Maryland, États-Unis, 21215
        • Retiré
        • Sinai Hospital Baltimore
    • Ohio
      • Garfield Heights, Ohio, États-Unis, 44125
        • Retiré
        • Cleveland Clinic - Sports Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15213
        • Recrutement
        • University of Pittsburgh
        • Chercheur principal:
          • Albert Lin
        • Contact:
          • Alec Howard
    • Texas
      • Bedford, Texas, États-Unis, 76021
        • Actif, ne recrute pas
        • Texas Orthopedic Specialists
      • The Woodlands, Texas, États-Unis, 77385
        • Retiré
        • Houston Methodist The Woodlands
    • Wisconsin
      • Ashland, Wisconsin, États-Unis, 54806
        • Retiré
        • Memorial Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Isolated Bioinductive Repair

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Dispositif: Isolated Bioinductive Repair

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

Autres noms:
  • Implant bioinductif REGENETEN™
Comparateur actif: Completion and Repair

Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
Procédure: Completion and Repair

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Western Ontario Rotator Cuff (WORC)
Délai: Change from baseline to 3 months post-intervention

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Western Ontario Rotator Cuff (WORC)
Délai: Pre-op, 6 weeks, 3, 6, 12 and 24 months

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 Score
Délai: Pre-Op, 3, 6, 12 and 24 months

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.
Pre-Op, 3, 6, 12 and 24 months
Subjective Shoulder Value (SSV) score
Délai: Pre-Op, 6 weeks, 3, 12 and 24 months

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).
Pre-Op, 6 weeks, 3, 12 and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
Délai: Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months

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.
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
Change in Western Ontario Rotator Cuff (WORC)
Délai: Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months

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

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.
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Change in Subjective Shoulder Value (SSV) score
Délai: Change from Pre-Op to 6 weeks, 3, 12 and 24 months

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).
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
Délai: Pre-Op, 3, 6, 12 and 24 months

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.
Pre-Op, 3, 6, 12 and 24 months
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
Délai: Pre-op, 6 weeks, 3, 6, 12 and 24 months

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) score
Délai: Pre-Op, 6 weeks, 3, 12 and 24 months

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).
Pre-Op, 6 weeks, 3, 12 and 24 months
Patient Satisfaction
Délai: 6 weeks, 3, 6, 12 and 24 months

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.
6 weeks, 3, 6, 12 and 24 months
Pain, Visual analog scale (VAS) Score
Délai: Pre-Op, 3 and 6 weeks, 3, 12 and 24 months

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.
Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
Délai: 12 months

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.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
Délai: 12 months

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%.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
Délai: 12 months

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.
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
Délai: 12 months

Tendon thickness will be measured in millimeters (mm).
12 months
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
Délai: 12 months

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.
12 months
Incidence of Revision Surgery
Délai: 1, 3 and 6 weeks, 3, 6, 12 and 24 months

Number of subjects requiring revision surgery
1, 3 and 6 weeks, 3, 6, 12 and 24 months
Time to return to work
Délai: Up to 24 months

Number of weeks taken to return to work following surgery
Up to 24 months
Time to return to driving
Délai: Up to 24 months

Number of weeks taken to return to driving following surgery
Up to 24 months
Time to return to sports
Délai: Up to 24 months

Number of weeks taken to return to sport following surgery
Up to 24 months
Total operative time
Délai: Inter-operative time

Time expressed in minutes
Inter-operative time
Physical Therapy Utilization
Délai: Up to 24 months

Number visits following index surgery
Up to 24 months
Cumulative days of opioid use
Délai: Day 1-14

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?'
Day 1-14
Duration of shoulder immobilization following index surgery
Délai: 1, 3 and 6 weeks, 3 months

Number of days
1, 3 and 6 weeks, 3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Smith & Nephew, Inc.

Les enquêteurs

  • Chaise d'étude: Laura Mills, Smith & Nephew, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 août 2022

Achèvement primaire (Estimé)

15 avril 2027

Achèvement de l'étude (Estimé)

28 février 2029

Dates d'inscription aux études

Première soumission

29 juin 2022

Première soumission répondant aux critères de contrôle qualité

29 juin 2022

Première publication (Réel)

6 juillet 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REGENETEN.2021.04

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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