Rotator Cuff TearsNCT03061942
Arthroscopic Rotator Cuff Repair With Synovectomy
A study testing Arthroscopic rotator cuff repair without synovectomy and Arthroscopic rotator cuff repair with synovectomy in people with Rotator Cuff Tears, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic rotator cuff repair without synovectomy and Arthroscopic rotator cuff repair with synovectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2017to 26 Oct 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair
Who cannot join
- History of shoulder surgery
- Acute trauma on affected shoulder
- Chronic dislocation
- Pyogenic infection
- Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
- Isolated subscapularis tear
Show all 16Show fewer
- Psychiatric problems that precluded informed consent
- An inability to read or write
- Other serious issues that precluded participation in the study
- Open surgery
- Rotator cuff tear with worker's compensation claim
- Refuse to participate in the study
- LOM that need brisement force
- Partial-thickness tear with focal full-thickness extension
- Irrepairable rotator cuff tear
- Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul
About this study
Official title: Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study
The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic rotator cuff repair without synovectomy, Arthroscopic rotator cuff repair with synovectomy
- 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 without synovectomyOther
30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.
Arthroscopic rotator cuff repair with synovectomyOther
30 subjects will undergo arthroscopic rotator cuff repair with synovectomy. Synovectomy is an operation performed to remove inflamed synovial membrane of a joint. Arthroscopic synovectomy will be performed with the use of a shaver and a cautery device through the portals for arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Arthroscopic rotator cuff repair without synovectomy Receives: Other: Arthroscopic rotator cuff repair without synovectomy |
| Synovectomy | Experimental | Arthroscopic rotator cuff repair with synovectomy Receives: Other: Arthroscopic rotator cuff repair with synovectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The worst pain VAS(visual analogue scale)
A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.
Measured: at 3 months after surgery
Secondary outcomes (2)
Constant-Murley score
The Constant-Murley score (CMS) is a 100-points scale composed of pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: at 3 months after surgery
The average pain VAS(visual analogue scale)
The average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.
Measured: at 3 months after surgery
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 start8 Mar 2017
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061942
- Sponsor's protocol ID
- BRM 17-01
- Status last verified
- Sep 2017
- First submitted
- 20 Feb 2017
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DM, Cho JW, Oh S, Jo CH. The Efficacy of Synovectomy in Rotator Cuff Repair: A Randomized Controlled Trial. Orthop J Sports Med. 2026 Aug 20;14(8):23259671261474635. doi: 10.1177/23259671261474635. eCollection 2026 Aug.
PubMed 42630550
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03061942
- Acronym / sponsor ID
- BRM 17-01
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- 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.
The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: Arthroscopic rotator cuff repair without synovectomyArthroscopic rotator cuff repair without synovectomy |
| Synovectomy | Experimental | Other: Arthroscopic rotator cuff repair with synovectomyArthroscopic rotator cuff repair with synovectomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair
Key exclusion criteria (16 listed)
- History of shoulder surgery
- Acute trauma on affected shoulder
- Chronic dislocation
- Pyogenic infection
- Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
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 without synovectomy30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy. | Other | Conventional |
| Arthroscopic rotator cuff repair with synovectomy30 subjects will undergo arthroscopic rotator cuff repair with synovectomy. Synovectomy is an operation performed to remove inflamed synovial membrane of a joint. Arthroscopic synovectomy will be performed with the use of a shaver and a cautery device through the portals for arthroscopic rotator cuff repair. | Other | Synovectomy |
Primary outcome
The worst pain VAS(visual analogue scale)
Time frame: at 3 months after surgery
A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.
2 secondary outcomes
Constant-Murley score
Time frame: at 3 months after surgery
The average pain VAS(visual analogue scale)
Time frame: at 3 months after surgery
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 31 Oct 2018.
- Derived from this study: PubMed 42630550Kim DM, Cho JW, Oh S, Jo CH. The Efficacy of Synovectomy in Rotator Cuff Repair: A Randomized Controlled Trial. Orthop J Sports Med. 2026 Aug 20;14(8):23259671261474635. doi: 10.1177/23259671261474635. eCollection 2026 Aug.
- 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.
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 without synovectomy and Arthroscopic rotator cuff repair with synovectomy in people with Rotator Cuff Tears, run by Seoul National University Hospital at 1 site in South Korea.
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 16 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 31 Oct 2018. 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 South Korea. 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 worst pain VAS(visual analogue scale) (time frame: at 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061942, which also lists 1 linked publication.
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 31 Oct 2018.