Rotator Cuff SyndromeNCT01987973
Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone
A study testing Partial Rotator Cuff Repair and Partial Rotator Cuff Repair with Allograft Augmentation in people with Rotator Cuff Syndrome and Rotator Cuff Injury, run by Ivan Wong at 1 site in Canada.
Trial summary
The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in 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 Syndrome, Rotator Cuff Injury, Disorder of Rotator Cuff
- What is being tested?
- Partial Rotator Cuff Repair and Partial Rotator Cuff Repair with Allograft Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Mar 2021
- 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
- Large/Massive rotator cuff tear >3cm proven on MRI
Who cannot join
- Non surgical candidate, unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft
The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.
Read the detailed description
A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. 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 Western Ontario Rotator Cuff Index (WORC) questionnaire.
The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.
- Conditions
- Rotator Cuff Syndrome, Rotator Cuff Injury, Disorder of Rotator Cuff, Full Thickness Rotator Cuff Tear, Skin Graft (Allograft) (Autograft) Failure
- Being tested
- Partial Rotator Cuff Repair, Partial Rotator Cuff Repair with Allograft Augmentation
- 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.
Partial Rotator Cuff RepairProcedure or surgery
Also called Debridement
This is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated.
Partial Rotator Cuff Repair with Allograft AugmentationProcedure or surgery
Also called Human dermal allograft, Allograft Reconstruction
Patients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. 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 at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated.
| Study group | Role | What they receive |
|---|---|---|
| Partial Repair / Debridement | Active comparator | Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group. Receives: Procedure: Partial Rotator Cuff Repair |
| Allograft Reconstruction | Experimental | Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation" Receives: Procedure: Partial Rotator Cuff Repair with Allograft Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff (WORC) Index
A patient questionnaire evaluating shoulder pain, function.
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 posted20 Nov 2013 (estimated)
- Study startFeb 2015
- Primary completionDec 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivan Wong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivan Wong, Nova Scotia Health Authority
- Investigators
- Ivan H Wong, MD FRCS(C), Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987973
- Sponsor's protocol ID
- 2014-182
- Status last verified
- Mar 2022
- First submitted
- 9 Nov 2013
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wong I, Sparavalo S, King JP, Coady CM. Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Oct;49(12):3173-3183. doi: 10.1177/03635465211039846. Epub 2021 Sep 8.
PubMed 34494901
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft
- ClinicalTrials.gov ID
- NCT01987973
- Acronym / sponsor ID
- 2014-182
- Conditions
- Rotator Cuff Syndrome, Rotator Cuff Injury, Disorder of Rotator Cuff, Full Thickness Rotator Cuff Tear, Skin Graft (Allograft) (Autograft) Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ivan WongUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 20 Nov 2013 (estimated)
- 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.
The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.
Detailed description
A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.
The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. 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 Western Ontario Rotator Cuff Index (WORC) questionnaire.
The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Repair / Debridement | Active comparator | Procedure: Partial Rotator Cuff RepairSubjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group. |
| Allograft Reconstruction | Experimental | Procedure: Partial Rotator Cuff Repair with Allograft AugmentationSubjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Large/Massive rotator cuff tear >3cm proven on MRI
Key exclusion criteria (1 listed)
- Non surgical candidate, unable to consent
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 |
|---|---|---|
| Partial Rotator Cuff RepairAlso: DebridementThis is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated. | Procedure or surgery | Partial Repair / Debridement |
| Partial Rotator Cuff Repair with Allograft AugmentationAlso: Human dermal allograft, Allograft ReconstructionPatients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. 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 at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated. | Procedure or surgery | Allograft Reconstruction |
Primary outcome
Western Ontario Rotator Cuff (WORC) Index
Time frame: 24 months
A patient questionnaire evaluating shoulder pain, function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 34494901Wong I, Sparavalo S, King JP, Coady CM. Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial. Am J Sports Med. 2021 Oct;49(12):3173-3183. doi: 10.1177/03635465211039846. Epub 2021 Sep 8.
- Individual participant dataSharing planned: No
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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 FRCS(C) 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 Partial Rotator Cuff Repair and Partial Rotator Cuff Repair with Allograft Augmentation in people with Rotator Cuff Syndrome and Rotator Cuff Injury, run by Ivan Wong 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 1 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: finished, as of the sponsor's last update on 8 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Western Ontario Rotator Cuff (WORC) Index (time frame: 24 months). 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 NCT01987973, which also lists 1 linked publication.
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 8 Mar 2022.