Rotator Cuff Tear ArthropathySCRNCT03425500
Massive Rotator Cuff Tear Reconstruction
A study testing Bridging Rotator Cuff Reconstruction, Superior Capsular Reconstruction and GRAFTJACKET™ allograft in people with Rotator Cuff Tear Arthropathy, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Bridging Rotator Cuff Reconstruction, Superior Capsular Reconstruction and GRAFTJACKET™ allograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2018to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
Who cannot join
- Presence of subscapular tear
- Presence of glenohumeral osteoarthritis
- WORC score > 70%
- Uncontrolled diabetes
- Pregnancy
- Presence of local or systemic infection
Show all 12Show fewer
- Paralysis of the shoulder
- Poor nutritional state
- Contracture of the shoulder
- Presence of cuff tear arthropathy
- MRI proven nonvascular surgical sites
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bridging Reconstruction of Massive Rotator Cuff Tears by Human Dermal Allograft Augmentation Compared to Superior Capsular Reconstruction
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.
Read the detailed description
A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the WORC questionnaire.
Surgical Technique
All patients will undergo a 15-point arthroscopic shoulder examination as per the method outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff can be re-approximated to its anatomic position on the greater tuberosity without excessive tension, a standard rotator cuff reconstruction will be attempted. If this is not possible the surgeon will determine that the cuff is "irreparable" and the randomization envelope will be opened.
Wong et al. described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
The technique described by Burkhart et al will be followed for patients in the "SCR" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. Measurement of defect size (coronal and sagittal) will take place, following that the glenoid and humeral footprint preparation will be performed utilizing an arthroscopic burr, arthroscopic bone anchors will be inserted on the glenoid footprint and graft is inserted with double pully technique. The graft is then tensioned to greater tuberosity using a double row configuration.
Postoperative protocol
The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively.
The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the (WORC) questionnaire at these follow-up appointments. Radiograph will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Bridging Rotator Cuff Reconstruction, Superior Capsular Reconstruction, GRAFTJACKET™ allograft
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridging Rotator Cuff ReconstructionProcedure or surgery
Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft
Superior Capsular ReconstructionProcedure or surgery
Superior Capsular Reconstruction of massive rotator cuff tear
GRAFTJACKET™ allograftDevice
Also called Acellular human dermal allograft
The acellular human dermal allograft in used in the bridging rotator cuff reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Bridging Rotator Cuff Group | Experimental | Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft. Receives: Procedure: Bridging Rotator Cuff Reconstruction; Device: GRAFTJACKET™ allograft |
| Superior Capsular Group | Active comparator | Superior Capsular Reconstruction of massive rotator cuff tear Receives: Procedure: Superior Capsular Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Acromiohumeral Distance
The primary objective of this study is to compare the effect between the two surgical techniques, arthroscopic SCR for a massive, chronic irreparable tear of the rotator cuff vs. BRR with an acellular human dermal allograft implant, on the maintenance of the Acromiohumeral distance. Acromiohumeral Distance is measured in mm and determine through xray.
Measured: 24 months
Secondary outcomes (3)
Changes in Shoulder Strength After Surgery
Changes in Strength After Surgery will be measured in kilograms using a hand dynamometer.
Measured: 24 months
Changes in Shoulder Range of Motion After Surgery
Changes in Shoulder Range of Motion After Surgery will be measured in degrees using a goniometer.
Measured: 24 months
Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)
The Western Ontario Rotator Cuff Index is a questionnaire use to evaluate patient reported outcomes. The questionnaire asks 21 questions are using a 100mm visual analogue type scale patients are asked to indicate how much pain they are experiencing doing different activities. The left end of the line indicates no pain, the right end of the line indicates extreme pain. The distance in mm from the left end of the line determines the amount of pain. To total distances for all 21 questions is added up then subtracted from 2100 and divided by 21 to give a percentage. A percentage of 100 indicates that no pain is being felt and low percentages indicates the patient is experiencing extreme pain.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 May 2018
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Wong, Nova Scotia Health Authority
- Investigators
- Ivan H Wong, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425500
- Sponsor's protocol ID
- IW-002
- Acronym
- SCR
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Reconstruction of Massive Rotator Cuff Tears by Human Dermal Allograft Augmentation Compared to Superior Capsular Reconstruction
- ClinicalTrials.gov ID
- NCT03425500
- Acronym / sponsor ID
- SCR / IW-002
- Conditions
- Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.
Detailed description
A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study. Routine radiographs including an AP and Y view of the shoulder as well as a pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the WORC questionnaire.
Surgical Technique
All patients will undergo a 15-point arthroscopic shoulder examination as per the method outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff can be re-approximated to its anatomic position on the greater tuberosity without excessive tension, a standard rotator cuff reconstruction will be attempted. If this is not possible the surgeon will determine that the cuff is "irreparable" and the randomization envelope will be opened.
Wong et al. described the surgical procedure for patients in the "Bridging" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed into the remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the greater tuberosity in a double row configuration.
The technique described by Burkhart et al will be followed for patients in the "SCR" group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities. Measurement of defect size (coronal and sagittal) will take place, following that the glenoid and humeral footprint preparation will be performed utilizing an arthroscopic burr, arthroscopic bone anchors will be inserted on the glenoid footprint and graft is inserted with double pully technique. The graft is then tensioned to greater tuberosity using a double row configuration.
Postoperative protocol
The shoulder will be immobilized in a sling for one week postoperatively, and only passive forward flexion and external rotation will be allowed for eight weeks. The patient then progresses to active shoulder motion. Strengthening will begin at twelve weeks postoperatively.
The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a wound check. Then further follow-up appointments will be at 6 weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant who is blinded to the patients' treatment group. The patient will also complete the (WORC) questionnaire at these follow-up appointments. Radiograph will be taken also to obtain the postoperative measurements. MRI will be done to assess healing at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Bridging Rotator Cuff Group | Experimental | Procedure: Bridging Rotator Cuff Reconstruction, Device: GRAFTJACKET™ allograftBridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft. |
| Superior Capsular Group | Active comparator | Procedure: Superior Capsular ReconstructionSuperior Capsular Reconstruction of massive rotator cuff tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
Key exclusion criteria (12 listed)
- Presence of subscapular tear
- Presence of glenohumeral osteoarthritis
- WORC score > 70%
- Uncontrolled diabetes
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridging Rotator Cuff ReconstructionBridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft | Procedure or surgery | Bridging Rotator Cuff Group |
| Superior Capsular ReconstructionSuperior Capsular Reconstruction of massive rotator cuff tear | Procedure or surgery | Superior Capsular Group |
| GRAFTJACKET™ allograftAlso: Acellular human dermal allograftThe acellular human dermal allograft in used in the bridging rotator cuff reconstruction | Device | Bridging Rotator Cuff Group |
Primary outcome
Maintenance of Acromiohumeral Distance
Time frame: 24 months
The primary objective of this study is to compare the effect between the two surgical techniques, arthroscopic SCR for a massive, chronic irreparable tear of the rotator cuff vs. BRR with an acellular human dermal allograft implant, on the maintenance of the Acromiohumeral distance. Acromiohumeral Distance is measured in mm and determine through xray.
3 secondary outcomes
Changes in Shoulder Strength After Surgery
Time frame: 24 months
Changes in Shoulder Range of Motion After Surgery
Time frame: 24 months
Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
Related trials for Rotator Cuff Tear Arthropathy
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
Enrolling by invitationPhase 1
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Rotator Cuff Tears, Rotator Cuff Injuries
Enrolling by invitation
Patient Education and Sling Use After Shoulder Surgery
Rotator Cuff Tear, Sling
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan H Wong, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridging Rotator Cuff Reconstruction, Superior Capsular Reconstruction and GRAFTJACKET™ allograft in people with Rotator Cuff Tear Arthropathy, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Acromiohumeral Distance (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2023.