Rotator Cuff TearPhase 4NCT00182299
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
A Phase 4 study testing porcine small intestine submucosa (SIS) in people with Rotator Cuff Tear, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- porcine small intestine submucosa (SIS)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Apr 2008
- Phase
- Phase 4
- 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
- Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).
Who cannot join
- Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
- Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
- Inability of the surgeon to repair the tear with less than 1cm of medialization,
- Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
- Active joint or systemic infection,
- Significant muscle paralysis of the shoulder girdle,
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- Major medical illness that would preclude undergoing surgery,
- Patients who are unwilling or unable to be assessed according to study protocol for one year following surgery
- Major psychiatric illness, developmental handicap or inability to read and understand the English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing the Effectiveness of Rotator Cuff Repair With or Without Augmentation With Porcine Small Intestine Submucosa (SIS) for Large Rotator Cuff Tears: Pilot Study Phase
The prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. To date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with SIS. Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative
Read the detailed description
Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patients with large rotator cuff tears.
Objectives of the pilot study
- To obtain a preliminary estimate of the likely success of SIS.
- To formally evaluate our ability to successfully recruit eligible patients into this study.
- To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair.
- To determine a more accurate estimation of sample size for the full trial using quality of life.
- To determine the frequency with which surgeons comply with the surgical protocol.
- To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.
- Conditions
- Rotator Cuff Tear
- Being tested
- porcine small intestine submucosa (SIS)
- 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.
porcine small intestine submucosa (SIS)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI defined failure of the cuff repair at 2 years postoperative
Secondary outcomes (1)
Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), DePuy Orthopaedics, London Health Sciences Centre
- Investigators
- Dianne M Bryant, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182299
- Sponsor's protocol ID
- 63140-1
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing the Effectiveness of Rotator Cuff Repair With or Without Augmentation With Porcine Small Intestine Submucosa (SIS) for Large Rotator Cuff Tears: Pilot Study Phase
- ClinicalTrials.gov ID
- NCT00182299
- Acronym / sponsor ID
- 63140-1
- Conditions
- Rotator Cuff Tear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), DePuy Orthopaedics, London Health Sciences Centre
- Study start
- Sep 2003
- Study completion
- Apr 2008 (estimated)
- First posted
- 16 Sep 2005 (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 prognosis for patients with large rotator cuff tears is poor. This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. To date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. We propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. Patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with SIS. Patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative
Detailed description
Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (SIS) in patients with large rotator cuff tears.
Objectives of the pilot study
- To obtain a preliminary estimate of the likely success of SIS.
- To formally evaluate our ability to successfully recruit eligible patients into this study.
- To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair.
- To determine a more accurate estimation of sample size for the full trial using quality of life.
- To determine the frequency with which surgeons comply with the surgical protocol.
- To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with large rotator cuff tears (Type 1B or Type 2) determined by clinical examination and diagnostic imaging. Criteria described by Harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (Type 0 = intact cuff, Type 1A = thinned cuff or partial thickness defect, Type 1B= full thickness defect on one tendon, Type 2 = full thickness defect of two tendons, Type 3 = full thickness defect of three tendons).
Key exclusion criteria (9 listed)
- Previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy.
- Inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter,
- Inability of the surgeon to repair the tear with less than 1cm of medialization,
- Evidence of other significant shoulder pathology including, Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis).
- Active joint or systemic infection,
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 |
|---|---|---|
| porcine small intestine submucosa (SIS) | Procedure or surgery | – |
Primary outcome
MRI defined failure of the cuff repair at 2 years postoperative
1 secondary outcome
Quality of life (WORC, ASES), function (SST, CONSTANT), general health (SF-36), pain (VAS), analgesic use; forward flexion; internal/external rotation; lateral elevation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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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.
Dianne M Bryant, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing porcine small intestine submucosa (SIS) in people with Rotator Cuff Tear, run by Hamilton Health Sciences Corporation 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 9 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 20 Apr 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MRI defined failure of the cuff repair at 2 years postoperative. 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 20 Apr 2007.