Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IVNCT01890733
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 Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV, run by OrthoSpace Ltd. at 1 site in Italy.
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
- Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
- What is being tested?
- Best Repair of torn Rotator Cuff and InSpace™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Sep 2015
- 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 (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) 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 Efficacy and Safety of InSpace™ Device in Comparison to 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 .
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).
- Being tested
- Best Repair of torn Rotator Cuff, InSpace™ system
- Keywords
- Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Repair of torn Rotator CuffDevice
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 debridment, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair. Receives: Device: Best Repair of torn Rotator Cuff |
| InSpace™ system | Active comparator | Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridment, 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.
Comparison of respose rate at each treatment arm
The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score
Measured: 6m
Secondary outcomes (2)
subjects requiring re-operation of the repaired tear at the end of the follow-up period.
Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.
Measured: 24 m post implantation
change of total questionnaires scores from baseline to each follow-up visit.
Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.
Measured: 6W, 3m, 6m , 12m ,24m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2015
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 Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IVStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoSpace Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Solimeno, MD, Principal investigator, Policlinico de Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890733
- Sponsor's protocol ID
- IS-CL-02
- Status last verified
- Sep 2012
- First submitted
- 27 Jun 2013
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. 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 Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
- ClinicalTrials.gov ID
- NCT01890733
- Acronym / sponsor ID
- IS-CL-02
- 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
- 5 participants (actual)
- Lead sponsor
- OrthoSpace Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Jul 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.
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 .
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 | Device: Best Repair of torn Rotator CuffSubjects will undergo surgical intervention (usually arthroscopy) to perform debridment, 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 debridment, 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 | Device | Best Repair of torn Rotator Cuff |
| InSpace™ system | Device | InSpace™ system |
Primary outcome
Comparison of respose rate at each treatment arm
Time frame: 6m
The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score
2 secondary outcomes
subjects requiring re-operation of the repaired tear at the end of the follow-up period.
Time frame: 24 m post implantation
change of total questionnaires scores from baseline to each follow-up visit.
Time frame: 6W, 3m, 6m , 12m ,24m
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 4 Jun 2020.
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.
Luigi Solimeno, MD principal investigator
Policlinico de Milano
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 Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV, run by OrthoSpace Ltd. at 1 site in Italy.
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 4 Jun 2020. 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 Italy. 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?
Comparison of respose rate at each treatment arm (time frame: 6m). 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 Jun 2020.