Rotator Cuff TearNCT03060928
Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
A study testing Arthroscopic Rotator Cuff Repair, Micro-perforations and Artelon® in people with Rotator Cuff Tear, run by ASST Gaetano Pini-CTO at 1 site in Italy.
Trial summary
Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic Rotator Cuff Repair, Micro-perforations and Artelon®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
- signed informed consensus
Who cannot join
- previous fractures
- diabetes
- subscapularis tears
- tears < 1cm or > 3 cm
- reduced passive range of motion
- infections
Show all 10Show fewer
- known mental or neurological disorders unwilling or unable to follow the post-surgery instructions
- conditions that contraindicate arthroscopic rotator cuff surgery
- patients without complete osteogenesis
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Italy1 site
Roberto Leo
Milan
Roberto Leo, 0258296798, spallagomito@gmail.com
Valentina Fogliata, dottoressa.fogliata@gmail.com
About this study
Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.
The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic Rotator Cuff Repair, Micro-perforations, Artelon®
- Keywords
- Rotator Cuff Tear, Artelon®
- 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.
Arthroscopic Rotator Cuff RepairProcedure or surgery
Arthroscopic Rotator Cuff Repair
Micro-perforationsProcedure or surgery
Biological stimulation with micro-perforations
Artelon®Procedure or surgery
Biological stimulation with Artelon® Tissue Reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Arthroscopic Rotator Cuff Repair with standard treatment Receives: Procedure: Arthroscopic Rotator Cuff Repair |
| Experimental 1 | Experimental | Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations Receives: Procedure: Arthroscopic Rotator Cuff Repair; Procedure: Micro-perforations |
| Experimental 2 | Experimental | Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement Receives: Procedure: Arthroscopic Rotator Cuff Repair; Procedure: Micro-perforations; Procedure: Artelon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear rate
Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging
Measured: 12 months post-operatively
Secondary outcomes (5)
Constant-Murley
Comparison of Constant-Murley Score in each group
Measured: 3, 6, 12 months post-operatively
DASH
Comparison of DASH Score in each group
Measured: 1, 3, 6, 12 months post-operatively
VAS
Comparison of Visual Analogue Scale (VAS) in each group
Measured: 1, 3, 6, 12 months post-operatively
Passive ROM
Comparison of passive range of motion in each group
Measured: 1, 3, 6, 12 months post-operatively
Adverse events
Adverse events for any cause
Measured: 1, 3, 6, 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Gaetano Pini-CTO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Leo, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060928
- Sponsor's protocol ID
- 753_2016
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
- ClinicalTrials.gov ID
- NCT03060928
- Acronym / sponsor ID
- 753_2016
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Artelon®
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ASST Gaetano Pini-CTOUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.
The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Arthroscopic Rotator Cuff RepairArthroscopic Rotator Cuff Repair with standard treatment |
| Experimental 1 | Experimental | Procedure: Arthroscopic Rotator Cuff Repair, Procedure: Micro-perforationsArthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with micro-perforations |
| Experimental 2 | Experimental | Procedure: Arthroscopic Rotator Cuff Repair, Procedure: Micro-perforations, Procedure: Artelon®Arthroscopic Rotator Cuff Repair with standard treatment + biological stimulation with the combination of micro-perforations and use of Artelon® Tissue Reinforcement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
- signed informed consensus
Key exclusion criteria (10 listed)
- previous fractures
- diabetes
- subscapularis tears
- tears < 1cm or > 3 cm
- reduced passive range of motion
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 |
|---|---|---|
| Arthroscopic Rotator Cuff RepairArthroscopic Rotator Cuff Repair | Procedure or surgery | Control, Experimental 1, Experimental 2 |
| Micro-perforationsBiological stimulation with micro-perforations | Procedure or surgery | Experimental 1, Experimental 2 |
| Artelon®Biological stimulation with Artelon® Tissue Reinforcement | Procedure or surgery | Experimental 2 |
Primary outcome
Retear rate
Time frame: 12 months post-operatively
Comparison of re-ruptures rate in each group evaluated with magnetic resonance imaging
5 secondary outcomes
Constant-Murley
Time frame: 3, 6, 12 months post-operatively
DASH
Time frame: 1, 3, 6, 12 months post-operatively
VAS
Time frame: 1, 3, 6, 12 months post-operatively
Passive ROM
Time frame: 1, 3, 6, 12 months post-operatively
Adverse events
Time frame: 1, 3, 6, 12 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Rotator Cuff Repair, Micro-perforations and Artelon® in people with Rotator Cuff Tear, run by ASST Gaetano Pini-CTO 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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retear rate (time frame: 12 months post-operatively). 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 Feb 2017.