Rotator Cuff TearNCT03609164
Does the Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
A study testing Suture-bridge augmentation of single-row repair in people with Rotator Cuff Tear, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Suture-bridge augmentation of single-row repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2015to 30 Jun 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
- patient was willing and able to provide scores for the study
Who cannot join
- irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
- glenohumeral or acromioclavicular joint osteoarthritis
- stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
- revision surgery
- patients with bacteremia, a systemic infection, or an infection at the surgical site
- patients who previously attempted or failed a treatment program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.
Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.
If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.
- Conditions
- Rotator Cuff Tear
- Being tested
- Suture-bridge augmentation of single-row repair
- Keywords
- arthroscopic surgery, massive rotator cuff repair, single-row repair, suture-spanning 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.
Suture-bridge augmentation of single-row repairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Suture-spanning augmentation of single-row repair | Experimental | Not described Receives: Procedure: Suture-bridge augmentation of single-row repair |
| single-row repair | Active comparator | Not described Receives: Procedure: Suture-bridge augmentation of single-row repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear rate
Using MR imaging to determine the presence or absence of rotator cuff retears
Measured: 6 months
Secondary outcomes (4)
Visual Analog Score (VAS)
Record the VAS (pain level from 0-10) by the questionnaire, pre-op/post-op 2-year
Measured: 2 years
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Record the ASES score by the questionnaire, focus on joint pain, instability, and activities of daily living, pre-op/post-op 2year
Measured: 2 years
University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
Record the UCLA shoulder score by the questionnaire, focusing on five sub-scales made up of: active forward elevation and strength (physician reported), pain, satisfaction, and function (patient reported), pre-op/post-op 2-year
Measured: 2 years
Shoulder constant score
Record the shoulder constant score by the questionnaire, focusing on ROM, functional assessment, strength measure, pre-op/post-op 2-year
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 May 2015
- Primary completion30 Apr 2016
- Study completion30 Jun 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hsiao-Li Ma, MD, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609164
- Sponsor's protocol ID
- 104-2314-B-075-082
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma HH, Chen KH, Chiang ER, Chou TA, Ma HL. Does Arthroscopic Suture-Spanning Augmentation of Single-Row Repair Reduce the Retear Rate of Massive Rotator Cuff Tear? Am J Sports Med. 2019 May;47(6):1420-1426. doi: 10.1177/0363546519836419. Epub 2019 Apr 18.
PubMed 30998402
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Arthroscopic Suture-spanning Augmentation of Single-row Repair in Massive Rotator Cuff Tear Reduce the Retear Rate?
- ClinicalTrials.gov ID
- NCT03609164
- Acronym / sponsor ID
- 104-2314-B-075-082
- Conditions
- Rotator Cuff Tear
- Keywords
- arthroscopic surgery, massive rotator cuff repair, single-row repair, suture-spanning augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Aug 2018 (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.
There are several associated structural changes when dealing with massive rotator cuff repair, which include tendon retraction and fragility, muscle atrophy and fatty infiltration, as well as osteoporosis over the tendon insertion. Those changes may lead to difficult in applying double-row repair, suture cutting through the tendon, too much tension over the repair and loosening or pull-out of anchors, which may results in poor tendon-bone healing and subsequent high re-tear rate. Therefore decreasing the tension over the repair site may increase the healing over tendon bone junction as well as decrease the risk of anchors loosening. A suture-spanning augmentation with two set of suture loops passing over musculotendinous junction medially and fixed with anchor at the lateral cortical wall may solve the problem. In order to define the clinical benefit of this adjuvant procedure, a prospective randomized control study is designed to compare the adjunctive reinforce suture with the single-row simple suture repair in massive rotator cuff tear.
Around sixty patients were randomized divided into two groups. The study group was used adjunctive reinforce suture repair technique, which was one lateral cortical anchor holding 2 separated set of transverse looping sutures over the medial musculotendinous junction in addition to single row repair, while the control group was used single row repair technique in simple stitch fashion. All patients will have clinical evaluation in pain (VAS score) and functional recovery (ASES and UCLA score) as well as MRI image for the tendon integrity.
If the suture-spanning augmentation of single-row repair can yield an improved healing rate and fewer complications, massive rotator cuff tear should be repaired earlier in order to prevent the late development of irreparable tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture-spanning augmentation of single-row repair | Experimental | Procedure: Suture-bridge augmentation of single-row repair |
| single-row repair | Active comparator | Procedure: Suture-bridge augmentation of single-row repair |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the pre-operative image (MRI) showing the massive rotator cuff tear (fulfilling one of the following definition a tear with a diameter of 5 cm or more; a complete tear of two or more tendons; one with a coronal length and sagittal width greater than or equal to 2 cm)
- patient was willing and able to provide scores for the study
Key exclusion criteria (6 listed)
- irreparable rotator cuff tear which was identified pre-operatively or intra-operatively
- glenohumeral or acromioclavicular joint osteoarthritis
- stage III or more of the fatty degenerative of supraspinatus in Goutallier classification
- revision surgery
- patients with bacteremia, a systemic infection, or an infection at the surgical site
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 |
|---|---|---|
| Suture-bridge augmentation of single-row repair | Procedure or surgery | Suture-spanning augmentation of single-row repair, single-row repair |
Primary outcome
Retear rate
Time frame: 6 months
Using MR imaging to determine the presence or absence of rotator cuff retears
4 secondary outcomes
Visual Analog Score (VAS)
Time frame: 2 years
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: 2 years
University of California at Los Angeles Shoulder Score (UCLA Shoulder Score)
Time frame: 2 years
Shoulder constant score
Time frame: 2 years
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 1 Aug 2018.
- Derived from this study: PubMed 30998402Ma HH, Chen KH, Chiang ER, Chou TA, Ma HL. Does Arthroscopic Suture-Spanning Augmentation of Single-Row Repair Reduce the Retear Rate of Massive Rotator Cuff Tear? Am J Sports Med. 2019 May;47(6):1420-1426. doi: 10.1177/0363546519836419. Epub 2019 Apr 18.
- 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.
Hsiao-Li Ma, MD study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-bridge augmentation of single-row repair in people with Rotator Cuff Tear, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 1 Aug 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 Taiwan. 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?
Retear rate (time frame: 6 months). 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 NCT03609164, 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 1 Aug 2018.