Arm InjuriesPhase 4NCT00208338
Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
A Phase 4 study testing RESTORE SIS Patch and Rotator cuff repair in people with Arm Injuries, run by DePuy International at 2 sites in 2 countries.
Trial summary
Primary Endpoints: Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of: Functional recovery (patient-based) - using the Oxford Shoulder Score. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arm Injuries
- What is being tested?
- RESTORE SIS Patch and Rotator cuff repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2005to Apr 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 40 and above.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects whose clinical symptoms and diagnosis suggest that they have a full-thickness rotator cuff tear (which includes but is not limited to the supraspinatus), which is degenerate in nature.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would prevent them from fulfilling the requirements of the Clinical Investigation Plan. (This should be detailed in the Screening Log.)
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- Subjects who are currently known to be involved in any injury litigation claims relating to the shoulder being treated as part of the study.
- Subjects with a known allergy to porcine material or who, for religious or other reasons, are unwilling to accept a porcine-derived implant.
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- Subjects who have undergone previous shoulder surgery (excluding purely-diagnostic arthroscopy).
- Subjects with significant paralysis of the shoulder.
- Subjects with inflammatory arthropathies.
- Subjects with active joint or systemic infection.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: A Prospective, Randomised Pilot Study to Determine the Variability of Early Clinical Outcome in Subjects Undergoing Full Thickness Rotator Cuff Tear Repair, When Augmented With or Without Porcine Small Intestine Submucosa (RESTORE)
Primary Endpoints:
Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of:
Read more
- Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Functional recovery and early return of strength (pain, activities of daily living [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder Assessment.
- Functional recovery (pain and function - patient-based), evaluated using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.
- Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.
- Range of motion - assessed by goniometer recorded as part of the Constant Score.
- Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and
- Record of escape pain medication usage (recorded in a daily patient diary).
Secondary Endpoints:
Comparative evaluation of any difference between the two groups in change from baseline to the 6-week time point, in terms of:
- Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a daily patient diary).
Comparative evaluation of any differences between the two groups in change from baseline to the 6-month time point, in terms of:
- Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated using the Constant Shoulder Assessment.
- Functional recovery (pain and function - patient-based), evaluated using the ASES Shoulder Assessment - patient self-report section.
- Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index.
- Range of motion - assessed by goniometer recorded as part of the Constant Score.
- Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a patient diary).
Comparative evaluation of any difference between the two groups in change from baseline to the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D instrument.
- Conditions
- Arm Injuries
- Being tested
- RESTORE SIS Patch, Rotator cuff repair
- Keywords
- Rotator cuff tear repair
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTORE SIS PatchDevice
Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement
Rotator cuff repairProcedure or surgery
Standard surgical repair of torn rotator cuff
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rotator cuff repair with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement Receives: Device: RESTORE SIS Patch |
| 2 | Active comparator | Standard rotator cuff repair Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months
Measured: 3 months
Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months
Measured: 3 months
Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months
Measured: 3 months
Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months
Measured: 3 months
Secondary outcomes (9)
Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks.
Measured: 6 weeks
Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months
Measured: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks
Measured: 6 weeks
Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months
Measured: 6 months
Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months
Measured: 6 months
Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months
Measured: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months
Measured: 3 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months
Measured: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2007
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm InjuriesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208338
- Sponsor's protocol ID
- CT 04/17
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Pilot Study to Determine the Variability of Early Clinical Outcome in Subjects Undergoing Full Thickness Rotator Cuff Tear Repair, When Augmented With or Without Porcine Small Intestine Submucosa (RESTORE)
- ClinicalTrials.gov ID
- NCT00208338
- Acronym / sponsor ID
- CT 04/17
- Conditions
- Arm Injuries
- Keywords
- Rotator cuff tear repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 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.
Primary Endpoints:
Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of:
- Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Functional recovery and early return of strength (pain, activities of daily living [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder Assessment.
- Functional recovery (pain and function - patient-based), evaluated using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.
- Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.
- Range of motion - assessed by goniometer recorded as part of the Constant Score.
- Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and
- Record of escape pain medication usage (recorded in a daily patient diary).
Secondary Endpoints:
Comparative evaluation of any difference between the two groups in change from baseline to the 6-week time point, in terms of:
- Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a daily patient diary).
Comparative evaluation of any differences between the two groups in change from baseline to the 6-month time point, in terms of:
- Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated using the Constant Shoulder Assessment.
- Functional recovery (pain and function - patient-based), evaluated using the ASES Shoulder Assessment - patient self-report section.
- Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index.
- Range of motion - assessed by goniometer recorded as part of the Constant Score.
- Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a patient diary).
Comparative evaluation of any difference between the two groups in change from baseline to the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: RESTORE SIS PatchRotator cuff repair with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement |
| 2 | Active comparator | Procedure: Rotator cuff repairStandard rotator cuff repair |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, aged 40 and above.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects whose clinical symptoms and diagnosis suggest that they have a full-thickness rotator cuff tear (which includes but is not limited to the supraspinatus), which is degenerate in nature.
Key exclusion criteria (10 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would prevent them from fulfilling the requirements of the Clinical Investigation Plan. (This should be detailed in the Screening Log.)
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- Subjects who are currently known to be involved in any injury litigation claims relating to the shoulder being treated as part of the study.
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 |
|---|---|---|
| RESTORE SIS PatchSurgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement | Device | 1 |
| Rotator cuff repairStandard surgical repair of torn rotator cuff | Procedure or surgery | 2 |
Primary outcome
Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months
Time frame: 3 months
Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months
Time frame: 3 months
Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months
Time frame: 3 months
Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months
Time frame: 3 months
9 secondary outcomes
Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks.
Time frame: 6 weeks
Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months
Time frame: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks
Time frame: 6 weeks
Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months
Time frame: 6 months
Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months
Time frame: 6 months
Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months
Time frame: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months
Time frame: 3 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months
Time frame: 6 months
Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months
Time frame: 12 months
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 4 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RESTORE SIS Patch and Rotator cuff repair in people with Arm Injuries, run by DePuy International at 2 sites in 2 countries.
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 4 inclusion and 10 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, United Kingdom. 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?
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?
Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months (time frame: 3 months). The study lists 4 primary outcomes in all. 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 4 Jul 2016.