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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05444465




Registration number
NCT05444465
Ethics application status
Date submitted
29/06/2022
Date registered
6/07/2022

Titles & IDs
Public title
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
Scientific 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)
Secondary ID [1] 0 0
REGENETEN.2021.04
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Injuries 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Isolated Bioinductive Repair
Treatment: Surgery - Completion and Repair

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

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


Treatment: Devices: Isolated Bioinductive Repair
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

Treatment: Surgery: Completion and Repair
Standard surgical repair using the 'Completion and Repair' technique.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Western Ontario Rotator Cuff (WORC)
Timepoint [1] 0 0
Change from baseline to 3 months post-intervention
Secondary outcome [1] 0 0
Western Ontario Rotator Cuff (WORC)
Timepoint [1] 0 0
Pre-op, 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [2] 0 0
Constant-Murley Score
Timepoint [2] 0 0
Pre-Op, 3, 6, 12 and 24 months
Secondary outcome [3] 0 0
Subjective Shoulder Value (SSV) score
Timepoint [3] 0 0
Pre-Op, 6 weeks, 3, 12 and 24 months
Secondary outcome [4] 0 0
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
Timepoint [4] 0 0
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [5] 0 0
Change in Western Ontario Rotator Cuff (WORC)
Timepoint [5] 0 0
Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [6] 0 0
Change in Constant-Murley Score
Timepoint [6] 0 0
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Secondary outcome [7] 0 0
Change in Subjective Shoulder Value (SSV) score
Timepoint [7] 0 0
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
Secondary outcome [8] 0 0
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
Timepoint [8] 0 0
Pre-Op, 3, 6, 12 and 24 months
Secondary outcome [9] 0 0
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
Timepoint [9] 0 0
Pre-op, 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [10] 0 0
Percent Achieving MCID for Subjective Shoulder Value (SSV) score
Timepoint [10] 0 0
Pre-Op, 6 weeks, 3, 12 and 24 months
Secondary outcome [11] 0 0
Patient Satisfaction
Timepoint [11] 0 0
6 weeks, 3, 6, 12 and 24 months
Secondary outcome [12] 0 0
Pain, Visual analog scale (VAS) Score
Timepoint [12] 0 0
Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
Secondary outcome [13] 0 0
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Incidence of Revision Surgery
Timepoint [18] 0 0
1, 3 and 6 weeks, 3, 6, 12 and 24 months
Secondary outcome [19] 0 0
Time to return to work
Timepoint [19] 0 0
Up to 24 months
Secondary outcome [20] 0 0
Time to return to driving
Timepoint [20] 0 0
Up to 24 months
Secondary outcome [21] 0 0
Time to return to sports
Timepoint [21] 0 0
Up to 24 months
Secondary outcome [22] 0 0
Total operative time
Timepoint [22] 0 0
Inter-operative time
Secondary outcome [23] 0 0
Physical Therapy Utilization
Timepoint [23] 0 0
Up to 24 months
Secondary outcome [24] 0 0
Cumulative days of opioid use
Timepoint [24] 0 0
Day 1-14
Secondary outcome [25] 0 0
Duration of shoulder immobilization following index surgery
Timepoint [25] 0 0
1, 3 and 6 weeks, 3 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
OrthoSport Victoria - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Italy
State/province [11] 0 0
Milano
Country [12] 0 0
Italy
State/province [12] 0 0
Roma
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Surrey
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Bath
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Bristol
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura Mills
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Judith Horner
Address 0 0
Country 0 0
Phone 0 0
+44 (0) 1482673251
Fax 0 0
Email 0 0
Judith.Horner@smith-nephew.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05444465