Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
ConditionRotator Cuff Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Isolated Bioinductive Repair
DeviceIsolated Bioinductive repair with REGENETEN™ Bioinductive Implant
Completion and Repair
Procedure/SurgeryStandard surgical repair using the 'Completion and Repair' technique.
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: Isolated Bioinductive RepairExperimental treatment 1 intervention
Group B: Completion and RepairActive comparator 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Change from baseline to 3 months post-interventionSecondary outcomes
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).
Time frame
Pre-op, 6 weeks, 3, 6, 12 and 24 months2
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.
Time frame
Pre-Op, 3, 6, 12 and 24 months3
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).
Time frame
Pre-Op, 6 weeks, 3, 12 and 24 months4
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.
Time frame
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov