Rotator Cuff TearNCT00916994
Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
A study testing SpaceGuard Balloon in people with Rotator Cuff Tear, run by OrthoSpace Ltd. at 1 site in Israel.
Trial summary
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace) Study… 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?
- SpaceGuard Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Diagnosed with Rotator Cuff tear and are scheduled for surgery.
- X-Ray of treated shoulder with no unrelated pathology and imaging (ultrasound or MRI) showing Rotator Cuff tear.
- Persistent pain and functional disability for at least 4 months.
- Documented failure of conservative treatment.
- Blood work up to two weeks before implantation as follow:
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- Normal CBC
- Normal electrolytes (potassium, chloride, phosphorous, sodium)
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 10.0 g/dl
- Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
- Adequate liver function, with serum bilirubin < 2.0 mg/dl
- Adequate liver function with SGOT/SGPT < 2.5 x the upper normal limit
- Normal values of the PT, PTT and INR tests
- Negative for HIV and Hepatitis B or C
- Mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements
- For Woman of Child Bearing Potential (WOCBP), negative pregnancy test and willingness to use birth control during the study.
- Singed Informed Consent Form.
Who cannot join
- Evidence of significant osteoarthritis or cartilage damage in the shoulder.
- Evidence of glenohumeral instability.
- Previous surgeries of the shoulder .
- Evidence of major joint trauma, infection, or necrosis in the shoulder.
- Patients unable to provide informed consent due to language barrier or mental status.
- Patients with a major medical condition that would affect quality of life and influence the results of the study (Including, but not limited to HIV, hepatitis, active malignancy in the past 5 years, transmural MI, CVA and other impaired neurological status, CHF or unstable angina in the past 6 months).
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- Patients unwilling to be followed for the duration of the study.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Other shoulder pain of unknown etiology.
- Paget's disease, osteomalacia or any other metabolic bone disease.
- Severe diabetes mellitus requiring daily insulin management.
- Bleeding disorders.
- Known cognitive disorder.
- Concurrent participation in any other clinical study.
- Physician objection.
- Subjects with sign of cervical root irritation.
- Chronic lung disease
- Trauma subjects
- For WOCBP, a positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-arm, International, Multi-center With Competitive Recruitment, Prospective Study to Assess the Safety and Efficacy of OrthoSpace's InSpace™ in Rotator Cuff Tear Subjects Scheduled for Surgery of the Rotator Cuff
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study
Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)
Read more
Study population: Rotator Cuff tear subjects scheduled for arthroscopy.
Number of subjects: Up to 70 subject for data analysis.
Number of sites: At least 4 sites in Israel.
Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.
Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant shoulder co morbidities.
Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post implantation, 3,6 and 12 months post implantation.
Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.
Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of Motion (ROM) and time to ROM with the SpaceGuard.
Primary end point: Serious Adverse Event rate related to the device and/or system complication.
Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard, migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of ROM and pain enhancement.
Read the detailed description
The OrthoSpace's InSpace™ biodegradable sub-acromial spacer (balloon) will be inserted at the end of the routine arthroscopy between the humerus head and the acromion.
- Conditions
- Rotator Cuff Tear
- Being tested
- SpaceGuard Balloon
- Keywords
- Rotator Cuff Tear
- 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.
SpaceGuard BalloonDevice
Positioning of the balloon into the subacromial space between the humerus head and the acromion
| Study group | Role | What they receive |
|---|---|---|
| SpaceGuard Balloon implantation | Experimental | Not described Receives: Device: SpaceGuard Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events.
Measured: 12-36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2014
- Study completionJun 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoSpace Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliyahu Adar, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916994
- Sponsor's protocol ID
- BP-04
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2009
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, International, Multi-center With Competitive Recruitment, Prospective Study to Assess the Safety and Efficacy of OrthoSpace's InSpace™ in Rotator Cuff Tear Subjects Scheduled for Surgery of the Rotator Cuff
- ClinicalTrials.gov ID
- NCT00916994
- Acronym / sponsor ID
- BP-04
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- OrthoSpace Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jun 2009 (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.
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study
Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)
Study population: Rotator Cuff tear subjects scheduled for arthroscopy.
Number of subjects: Up to 70 subject for data analysis.
Number of sites: At least 4 sites in Israel.
Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.
Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant shoulder co morbidities.
Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post implantation, 3,6 and 12 months post implantation.
Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.
Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of Motion (ROM) and time to ROM with the SpaceGuard.
Primary end point: Serious Adverse Event rate related to the device and/or system complication.
Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard, migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of ROM and pain enhancement.
Detailed description
The OrthoSpace's InSpace™ biodegradable sub-acromial spacer (balloon) will be inserted at the end of the routine arthroscopy between the humerus head and the acromion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpaceGuard Balloon implantation | Experimental | Device: SpaceGuard Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 or older.
- Diagnosed with Rotator Cuff tear and are scheduled for surgery.
- X-Ray of treated shoulder with no unrelated pathology and imaging (ultrasound or MRI) showing Rotator Cuff tear.
- Persistent pain and functional disability for at least 4 months.
- Documented failure of conservative treatment.
Key exclusion criteria (19 listed)
- Evidence of significant osteoarthritis or cartilage damage in the shoulder.
- Evidence of glenohumeral instability.
- Previous surgeries of the shoulder .
- Evidence of major joint trauma, infection, or necrosis in the shoulder.
- Patients unable to provide informed consent due to language barrier or mental status.
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 |
|---|---|---|
| SpaceGuard BalloonPositioning of the balloon into the subacromial space between the humerus head and the acromion | Device | SpaceGuard Balloon implantation |
Primary outcome
The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events.
Time frame: 12-36 months follow-up
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 11 Mar 2015.
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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.
Eliyahu Adar, MD principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpaceGuard Balloon in people with Rotator Cuff Tear, run by OrthoSpace Ltd. at 1 site in Israel.
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 19 inclusion and 19 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 11 Mar 2015. 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 Israel. 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?
The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events. (time frame: 12-36 months follow-up). 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 11 Mar 2015.