Rotator Cuff TearNCT02208453
InSpace™ System Implantation in a Procedure Under Local Anesthesia
A study testing InSpace Implantation in people with Rotator Cuff Tear, run by OrthoSpace Ltd. at 1 site in Italy.
Trial summary
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- InSpace Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Apr 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 or older.
- Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
- Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.
Who cannot join
- Known allergy to the balloon material
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of gleno-humeral instability
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
- Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
- Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
Read the detailed description
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.
Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.
Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.
Subjects will then be followed for safety and efficacy for a 24 months following the implantation.
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
The efficacy will be assess by using Constant and ASES outcome score The Constant and the ASES will be completed by the investigator at each study visit .The patient will complete the patient self-evaluation part of the ASES at each study visit.
The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout the entire study period.
- Conditions
- Rotator Cuff Tear
- Being tested
- InSpace Implantation
- Keywords
- Massive Rotator Cuff Tear, Local anesthesia, Sub-acromial spacer
- 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.
InSpace ImplantationDevice
InSpace device Implantation
| Study group | Role | What they receive |
|---|---|---|
| InSpace implantation | Experimental | InSpace device implantation Receives: Device: InSpace Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total shoulder outcome scores (Constant and ASES)
Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
Measured: 6 months post implanatation
Secondary outcomes (1)
Change in Total Shoulder scores
Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).
Measured: up to 24 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2018
- Study completionApr 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoSpace Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrico Gervasi, MD, Principal investigator, Orthopedic Department, Latisana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208453
- Sponsor's protocol ID
- IS-CL-05
- Other IDs
- 72746
- Status last verified
- Aug 2019
- First submitted
- 29 Jun 2013
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT02208453
- Acronym / sponsor ID
- IS-CL-05
- Conditions
- Rotator Cuff Tear
- Keywords
- Massive Rotator Cuff Tear, Local anesthesia, Sub-acromial spacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- OrthoSpace Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 5 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.
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
Detailed description
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.
Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.
Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.
Subjects will then be followed for safety and efficacy for a 24 months following the implantation.
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
The efficacy will be assess by using Constant and ASES outcome score The Constant and the ASES will be completed by the investigator at each study visit .The patient will complete the patient self-evaluation part of the ASES at each study visit.
The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSpace implantation | Experimental | Device: InSpace ImplantationInSpace device implantation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 or older.
- Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
- Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.
Key exclusion criteria (7 listed)
- Known allergy to the balloon material
- Evidence of significant osteoarthritis or cartilage damage in the shoulder
- Evidence of gleno-humeral instability
- Evidence of major joint trauma, infection, or necrosis in the shoulder
- Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results 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 |
|---|---|---|
| InSpace ImplantationInSpace device Implantation | Device | InSpace implantation |
Primary outcome
Change in total shoulder outcome scores (Constant and ASES)
Time frame: 6 months post implanatation
Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
1 secondary outcome
Change in Total Shoulder scores
Time frame: up to 24 months post implantation
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 28 Aug 2019.
- Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.Link provided by the sponsor.
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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.
Enrico Gervasi, MD principal investigator
Orthopedic Department, Latisana Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InSpace Implantation in people with Rotator Cuff Tear, 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?
The sponsor lists 3 inclusion and 7 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 28 Aug 2019. 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. 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?
Change in total shoulder outcome scores (Constant and ASES) (time frame: 6 months post implanatation). 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 28 Aug 2019.