Rotator Cuff TearNCT02976285
Polyester Patch in Massive Rotator Cuff Repair Improves Healing
An observational study of Rotator Cuff Tear, run by Etzel Clinic.
Trial summary
The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- arthroscopic rotator cuff repair with a polyester patch
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2015
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the time of surgery was 65 years (range 41 - 75).
Who may be able to join
- Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.
Who cannot join
- We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.
About this study
Official title: Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity
The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.
Read the detailed description
To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.
- Conditions
- Rotator Cuff Tear
- Being tested
- arthroscopic rotator cuff repair with a polyester patch
- Keywords
- arthroscopic rotator cuff repair, patch augmentation
- 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 repair with a polyester patchProcedure or surgery
Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.
What is being measured
The primary outcome is the main question the study is designed to answer.
Function assessed with the Constant-Murley-Score
Measured: 25 months
Function assessed with the Subjective Shoulder Value
Measured: 25 months
Secondary outcomes (1)
Tendon integrity evaluated radiologically
Measured: 1-35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etzel Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976285
- Sponsor's protocol ID
- PitchPatch54
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity
- ClinicalTrials.gov ID
- NCT02976285
- Acronym / sponsor ID
- PitchPatch54
- Conditions
- Rotator Cuff Tear
- Keywords
- arthroscopic rotator cuff repair, patch augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Etzel ClinicUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Nov 2016 (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 purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.
Detailed description
To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the time of surgery was 65 years (range 41 - 75).
Key inclusion criteria (1 listed)
- Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.
Key exclusion criteria (1 listed)
- We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.
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 repair with a polyester patchPatients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch. | Procedure or surgery | – |
Primary outcome
Function assessed with the Constant-Murley-Score
Time frame: 25 months
Function assessed with the Subjective Shoulder Value
Time frame: 25 months
1 secondary outcome
Tendon integrity evaluated radiologically
Time frame: 1-35 months
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 29 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Etzel Clinic.
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 1 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Function assessed with the Constant-Murley-Score (time frame: 25 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 29 Nov 2016.