Subscapularis Tendon TearNCT03183466
Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?
A study testing arthroscopic repair and arthroscopic debridement in people with Subscapularis Tendon Tear and Arthroscopic Repair, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subscapularis Tendon Tear, Arthroscopic Repair, Arthroscopic Debridement
- What is being tested?
- arthroscopic repair and arthroscopic debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2011to 1 Jul 2017
- 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
- Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
- Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
- Combined biceps lesion
- Combined acromial clavicle (AC) arthritis
Who cannot join
- Revision case or previous surgical history of the index shoulder
- Any open surgery, including open repair of the subscapularis tendon
- Compensation case
- Combined severe arthritis of the glenohumeral joint
- Patient who selects one's own surgical method, i.e. not randomized
- Infection, tumor, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)
The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.
Read the detailed description
The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.
- Being tested
- arthroscopic repair, arthroscopic debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic repairProcedure or surgery
arthroscopic debridementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients included in inclusion criteria | Experimental | Not described Receives: Procedure: arthroscopic repair; Procedure: arthroscopic debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
Measured: 2 year postoperatively
Pain Visual Analogue Scale (PVAS)
Measured: 2 year postoperatively
American Shoulder and Elbow Surgeons' score
Measured: 2 year postoperatively
Constant score
Measured: 2 year postoperatively
Korean Shoulder Score (KSS) score
Measured: 2 year postoperatively
Secondary outcomes (1)
repair integrity analysis using postoperative MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Dec 2011
- Primary completion30 Nov 2014
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subscapularis Tendon TearStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183466
- Sponsor's protocol ID
- 2011-11-029-025
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burkhart SS, Tehrany AM. Arthroscopic subscapularis tendon repair: Technique and preliminary results. Arthroscopy. 2002 May-Jun;18(5):454-63. doi: 10.1053/jars.2002.30648.
PubMed 11987054Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.
PubMed 22632896Flury MP, John M, Goldhahn J, Schwyzer HK, Simmen BR. Rupture of the subscapularis tendon (isolated or in combination with supraspinatus tear): when is a repair indicated? J Shoulder Elbow Surg. 2006 Nov-Dec;15(6):659-64. doi: 10.1016/j.jse.2005.07.013. Epub 2006 Oct 19.
PubMed 17055750Jeong JY, Kim SC, Lee SM, Yoo JC. Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Partial Subscapularis Tendon Tears More Than Half of the Entire First Facet. Am J Sports Med. 2023 Sep;51(11):2804-2814. doi: 10.1177/03635465231187033. Epub 2023 Aug 7.
PubMed 37548022
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)
- ClinicalTrials.gov ID
- NCT03183466
- Acronym / sponsor ID
- 2011-11-029-025
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 12 Jun 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 was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.
Detailed description
The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included in inclusion criteria | Experimental | Procedure: arthroscopic repair, Procedure: arthroscopic debridement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
- Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
- Combined biceps lesion
- Combined acromial clavicle (AC) arthritis
Key exclusion criteria (6 listed)
- Revision case or previous surgical history of the index shoulder
- Any open surgery, including open repair of the subscapularis tendon
- Compensation case
- Combined severe arthritis of the glenohumeral joint
- Patient who selects one's own surgical method, i.e. not randomized
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 repair | Procedure or surgery | Patients included in inclusion criteria |
| arthroscopic debridement | Procedure or surgery | Patients included in inclusion criteria |
Primary outcome
Range of Motion (ROM)
Time frame: 2 year postoperatively
Pain Visual Analogue Scale (PVAS)
Time frame: 2 year postoperatively
American Shoulder and Elbow Surgeons' score
Time frame: 2 year postoperatively
Constant score
Time frame: 2 year postoperatively
Korean Shoulder Score (KSS) score
Time frame: 2 year postoperatively
1 secondary outcome
repair integrity analysis using postoperative MRI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Background: PubMed 11987054Burkhart SS, Tehrany AM. Arthroscopic subscapularis tendon repair: Technique and preliminary results. Arthroscopy. 2002 May-Jun;18(5):454-63. doi: 10.1053/jars.2002.30648.
- Background: PubMed 22632896Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.
- Background: PubMed 17055750Flury MP, John M, Goldhahn J, Schwyzer HK, Simmen BR. Rupture of the subscapularis tendon (isolated or in combination with supraspinatus tear): when is a repair indicated? J Shoulder Elbow Surg. 2006 Nov-Dec;15(6):659-64. doi: 10.1016/j.jse.2005.07.013. Epub 2006 Oct 19.
- Derived from this study: PubMed 37548022Jeong JY, Kim SC, Lee SM, Yoo JC. Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Partial Subscapularis Tendon Tears More Than Half of the Entire First Facet. Am J Sports Med. 2023 Sep;51(11):2804-2814. doi: 10.1177/03635465231187033. Epub 2023 Aug 7.
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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 repair and arthroscopic debridement in people with Subscapularis Tendon Tear and Arthroscopic Repair, run by Samsung Medical Center 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 4 inclusion and 6 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 12 Jun 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 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?
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?
Range of Motion (ROM) (time frame: 2 year postoperatively). The study lists 5 primary outcomes in all. 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 NCT03183466, which also lists 4 linked publications.
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 12 Jun 2017.