Rotator Cuff TearNCT02211183
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
A study testing Best Repair of torn Rotator Cuff and InSpace™ system in people with Rotator Cuff Tear, run by OrthoSpace Ltd. at 1 site in Spain.
Trial summary
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear . Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Best Repair of torn Rotator Cuff and InSpace™ system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2014to Feb 2016
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Age 40 or older.
- Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
- Persistent pain and functional disability of the affected shoulder for at least 3 months.
Main Exclusion Criteria :
- Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of gleno-humeral instability
- Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Partial-thickness tears of the rotator cuff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
Read the detailed description
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
- Conditions
- Rotator Cuff Tear
- Being tested
- Best Repair of torn Rotator Cuff, InSpace™ system
- Keywords
- Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
- 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.
Best Repair of torn Rotator CuffProcedure or surgery
InSpace™ systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Best Repair of torn Rotator Cuff | Sham comparator | Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair. Receives: Procedure: Best Repair of torn Rotator Cuff |
| InSpace™ system | Active comparator | Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system. Receives: Device: InSpace™ system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Shoulder Score from baseline
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionFeb 2016
Why it stopped: Very Low recruitment rate
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoSpace Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilio Calvo, MD, Principal investigator, Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211183
- Sponsor's protocol ID
- IS-CL-02-SP
- Status last verified
- May 2016
- First submitted
- 6 Aug 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
- ClinicalTrials.gov ID
- NCT02211183
- Acronym / sponsor ID
- IS-CL-02-SP
- Conditions
- Rotator Cuff Tear
- Keywords
- Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very Low recruitment rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OrthoSpace Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Aug 2014 (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.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
Detailed description
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Repair of torn Rotator Cuff | Sham comparator | Procedure: Best Repair of torn Rotator CuffSubjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair. |
| InSpace™ system | Active comparator | Device: InSpace™ systemSubjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Best Repair of torn Rotator Cuff | Procedure or surgery | Best Repair of torn Rotator Cuff |
| InSpace™ system | Device | InSpace™ system |
Primary outcome
The change in Shoulder Score from baseline
Time frame: baseline and 6 months
Results and safety
The study was stopped early (reason given: Very Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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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.
Emilio Calvo, MD principal investigator
Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Repair of torn Rotator Cuff and InSpace™ system in people with Rotator Cuff Tear, run by OrthoSpace Ltd. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 6 Apr 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Very Low recruitment rate). 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?
The change in Shoulder Score from baseline (time frame: baseline and 6 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 6 Apr 2018.