Rupture of the Rotator CuffNCT02097901
Microfracture in Rotator Cuff Injury Repair
A study testing Microfracture and NO microfracture in people with Rupture of the Rotator Cuff, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rupture of the Rotator Cuff
- What is being tested?
- Microfracture and NO microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Mar 2018
- 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
- Patients over the age of 18 with a full thickness rotatorcuff rupture.
Who cannot join
- Isolated rupture of the subscapularis
- Tendon atrophia
- Goutallier grade 3-4 fatty degeneration
- Fracture surgery in same shoulder
- Inflammatory or neurologic affection of shoulder
- Other disabling disease
- Unwilling to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.
- Conditions
- Rupture of the Rotator Cuff
- Being tested
- Microfracture, NO microfracture
- Keywords
- Rotator Cuff, Injury, Repair, Microfracture, Healing
- Medical subject headings
- Wounds and Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrofractureProcedure or surgery
Rotator Cuff Repair AND Microfracture
NO microfractureProcedure or surgery
Rotator Cuff Repair without microfracture
| Study group | Role | What they receive |
|---|---|---|
| Microfracture | Experimental | Rotator Cuff Repair AND Microfracture at rotatorcuff footprint Receives: Procedure: Microfracture |
| NO microfracture | Active comparator | Rotator cuff reinsertion without microfracture Receives: Procedure: NO microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario Rotator Cuff Index (WORC)
Standardized questionnaire
Measured: 0, 3 and 12 months
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Standardized questionnaire
Measured: 0, 3 and 12 months
Secondary outcomes (1)
MRI integrity of the rotatorcuff
- Intact rotatorcuff
- Partial rupture
- Full thickness rupture
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Insufficient patient material
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of the Rotator CuffStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten S. Wad, Zealand University Hospital
- Investigators
- Lars Blønd, M.D, Study director, Køge SygehusGunner S Barfoed, M.D, Study director, Køge SygehusThomas JN Sørensen, M.D, Study director, Køge Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097901
- Sponsor's protocol ID
- SJ-370
- Status last verified
- Jan 2017
- First submitted
- 17 Mar 2014
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfracture in Rotator Cuff Injury Repair
- ClinicalTrials.gov ID
- NCT02097901
- Acronym / sponsor ID
- SJ-370
- Conditions
- Rupture of the Rotator Cuff
- Keywords
- Rotator Cuff, Injury, Repair, Microfracture, Healing
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Insufficient patient material
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 27 Mar 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 hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microfracture | Experimental | Procedure: MicrofractureRotator Cuff Repair AND Microfracture at rotatorcuff footprint |
| NO microfracture | Active comparator | Procedure: NO microfractureRotator cuff reinsertion without microfracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 with a full thickness rotatorcuff rupture.
Key exclusion criteria (7 listed)
- Isolated rupture of the subscapularis
- Tendon atrophia
- Goutallier grade 3-4 fatty degeneration
- Fracture surgery in same shoulder
- Inflammatory or neurologic affection of shoulder
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 |
|---|---|---|
| MicrofractureRotator Cuff Repair AND Microfracture | Procedure or surgery | Microfracture |
| NO microfractureRotator Cuff Repair without microfracture | Procedure or surgery | NO microfracture |
Primary outcome
Change in Western Ontario Rotator Cuff Index (WORC)
Time frame: 0, 3 and 12 months
Standardized questionnaire
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
Time frame: 0, 3 and 12 months
Standardized questionnaire
1 secondary outcome
MRI integrity of the rotatorcuff
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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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.
Lars Blønd, M.D study director
Køge Sygehus
Gunner S Barfoed, M.D study director
Køge Sygehus
Thomas JN Sørensen, M.D study director
Køge Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfracture and NO microfracture in people with Rupture of the Rotator Cuff, run by Zealand University Hospital at 1 site in Denmark.
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 1 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: paused, as of the sponsor's last update on 30 Jan 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 Denmark. 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?
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 Western Ontario Rotator Cuff Index (WORC) (time frame: 0, 3 and 12 months). The study lists 2 primary outcomes in all. 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 30 Jan 2017.