Rotator Cuff TearsNCT04587180
Cutting-through at the Greater Tuberosity
An observational study of Rotator Cuff Tears, run by Chuncheon Sacred Heart Hospital.
Trial summary
The investigators evaluated the correlation between cutting-through at the greater tuberosity (GT) just medial to the lateral knotless anchor in arthroscopic suture-bridge rotator cuff repair and the bone mineral density (BMD) of the lumbar spine, hip and GT of the proximal humerus and to evaluate factors and clinical… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic suture-bridge rotator cuff repair
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Dec 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears
Who may be able to join
- Primary arthroscopic repair for a symptomatic full-thickness rotator cuff tear identified by preoperative MRI
- Dual energy X-ray absorptiometry (DEXA) to evaluate the BMD of the lumbar spine and hip, as a standardized measurement, and the GT of the affected proximal humerus
- Follow up for a minimum of 2 years after the primary surgery.
Who cannot join
- Primary arthroscopic repair due to partial-thickness rotator cuff tear or an isolated subscapularis tear
- Primary suture-bridge repair with 3 or more lateral-knotless anchors
- Previous history of fractures or surgeries on the affected shoulder
- Shoulder instability
- Glenohumeral osteoarthritis
- Neurologic or systemic disease diseases influencing the shoulder joint 7 History of infection of the shoulder joint
About this study
Official title: The Correlation Between the Bone Mineral Density of the Proximal Humerus and Cutting-through at the Greater Tuberosity in Arthroscopic Suture-bridge Rotator Cuff Repair
The investigators evaluated the correlation between cutting-through at the greater tuberosity (GT) just medial to the lateral knotless anchor in arthroscopic suture-bridge rotator cuff repair and the bone mineral density (BMD) of the lumbar spine, hip and GT of the proximal humerus and to evaluate factors and clinical outcomes related to cutting-through at the GT.
Read the detailed description
Seventy-eight patients who underwent arthroscopic suture-bridge rotator cuff repair and who had undergone dual energy X-ray absorptiometry (DEXA) scans before surgery were included. Patients were divided into two groups: patients who had cutting-through (46, group I) and patients who did not (32, group II). Clinical and radiological data including demographics, BMDs, fatty infiltration of rotator cuff muscles, tear size, tear involvement, VAS pain score, and ASES score were analyzed.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic suture-bridge rotator cuff repair
- Keywords
- rotator cuff tear, cutting-through, Bone mineral density, suture-bridge repair
- 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 suture-bridge rotator cuff repairProcedure or surgery
Arthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cutting-through | Patients who had cutting-through during the lateral knotless anchor fixation. Receives: Procedure: Arthroscopic suture-bridge rotator cuff repair | |
| Patients without cutting-through | Patients who didn't have cutting-through during the lateral knotless anchor fixation. Receives: Procedure: Arthroscopic suture-bridge rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of cutting-through
The occurrence of cortical breakage of the GT just medial to the lateral knotless anchor hole due to the tension of the sutures from the medial anchor
Measured: During the surgery
Visual Analog Scale (VAS) Pain Score
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
Measured: 2 years after surgery
American Shoulder and Elbow Surgeons (ASES) score
American Shoulder and Elbow Surgeons score for estimating shoulder function was based on a score from 0 to 100, where 0 indicated poor outcome and 100 indicated excellent outcome.
Measured: 2 years after surgery
Greater tuberosity bone mineral density
GT BMD was measured using the predefined region of interest (ROI). Dividing the humeral head into three columns of even width, we defined a 1x1-cm2-sized square in the center of the lateral column as ROI.
Measured: preoperatively
Lumbar spine bone mineral density
Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
Measured: preoperatively
Hip bone mineral density
Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
Measured: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jun 2014
- Primary completion31 Oct 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
- Investigators
- Jung-Taek Hwang, MD, PhD, Principal investigator, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587180
- Sponsor's protocol ID
- 2014-33
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh JH, Song BW, Lee YS. Measurement of volumetric bone mineral density in proximal humerus using quantitative computed tomography in patients with unilateral rotator cuff tear. J Shoulder Elbow Surg. 2014 Jul;23(7):993-1002. doi: 10.1016/j.jse.2013.09.024. Epub 2013 Dec 31.
PubMed 24388151Oh JH, Song BW, Kim SH, Choi JA, Lee JW, Chung SW, Rhie TY. The measurement of bone mineral density of bilateral proximal humeri using DXA in patients with unilateral rotator cuff tear. Osteoporos Int. 2014 Nov;25(11):2639-48. doi: 10.1007/s00198-014-2795-1. Epub 2014 Jul 16.
PubMed 25027108Pogorzelski J, Fritz EM, Horan MP, Katthagen JC, Hussain ZB, Godin JA, Millett PJ. Minimum Five-year Outcomes and Clinical Survivorship for Arthroscopic Transosseous-equivalent Double-row Rotator Cuff Repair. J Am Acad Orthop Surg. 2019 Dec 15;27(24):e1093-e1101. doi: 10.5435/JAAOS-D-18-00519.
PubMed 31805019Ono Y, Woodmass JM, Nelson AA, Boorman RS, Thornton GM, Lo IK. Knotless anchors with sutures external to the anchor body may be at risk for suture cutting through osteopenic bone. Bone Joint Res. 2016 Jun;5(6):269-75. doi: 10.1302/2046-3758.56.2000535.
PubMed 27357383Lee S, Hwang JT, Lee SS, Lee JH, Kim TY. Greater Tuberosity Bone Mineral Density and Rotator Cuff Tear Size Are Independent Factors Associated With Cutting-Through in Arthroscopic Suture-Bridge Rotator Cuff Repair. Arthroscopy. 2021 Jul;37(7):2077-2086. doi: 10.1016/j.arthro.2021.01.059. Epub 2021 Feb 10.
PubMed 33581302
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Bone Mineral Density of the Proximal Humerus and Cutting-through at the Greater Tuberosity in Arthroscopic Suture-bridge Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04587180
- Acronym / sponsor ID
- 2014-33
- Conditions
- Rotator Cuff Tears
- Keywords
- rotator cuff tear, cutting-through, Bone mineral density, suture-bridge repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 14 Oct 2020 (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 investigators evaluated the correlation between cutting-through at the greater tuberosity (GT) just medial to the lateral knotless anchor in arthroscopic suture-bridge rotator cuff repair and the bone mineral density (BMD) of the lumbar spine, hip and GT of the proximal humerus and to evaluate factors and clinical outcomes related to cutting-through at the GT.
Detailed description
Seventy-eight patients who underwent arthroscopic suture-bridge rotator cuff repair and who had undergone dual energy X-ray absorptiometry (DEXA) scans before surgery were included. Patients were divided into two groups: patients who had cutting-through (46, group I) and patients who did not (32, group II). Clinical and radiological data including demographics, BMDs, fatty infiltration of rotator cuff muscles, tear size, tear involvement, VAS pain score, and ASES score were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cutting-through | – | Procedure: Arthroscopic suture-bridge rotator cuff repairPatients who had cutting-through during the lateral knotless anchor fixation. |
| Patients without cutting-through | – | Procedure: Arthroscopic suture-bridge rotator cuff repairPatients who didn't have cutting-through during the lateral knotless anchor fixation. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with arthroscopic rotator cuff suture-bridge repair for full-thickness rotator cuff tears
Key inclusion criteria (3 listed)
- Primary arthroscopic repair for a symptomatic full-thickness rotator cuff tear identified by preoperative MRI
- Dual energy X-ray absorptiometry (DEXA) to evaluate the BMD of the lumbar spine and hip, as a standardized measurement, and the GT of the affected proximal humerus
- Follow up for a minimum of 2 years after the primary surgery.
Key exclusion criteria (6 listed)
- Primary arthroscopic repair due to partial-thickness rotator cuff tear or an isolated subscapularis tear
- Primary suture-bridge repair with 3 or more lateral-knotless anchors
- Previous history of fractures or surgeries on the affected shoulder
- Shoulder instability
- Glenohumeral 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 suture-bridge rotator cuff repairArthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors. | Procedure or surgery | Patients with cutting-through, Patients without cutting-through |
Primary outcome
The occurrence of cutting-through
Time frame: During the surgery
The occurrence of cortical breakage of the GT just medial to the lateral knotless anchor hole due to the tension of the sutures from the medial anchor
Visual Analog Scale (VAS) Pain Score
Time frame: 2 years after surgery
The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
American Shoulder and Elbow Surgeons (ASES) score
Time frame: 2 years after surgery
American Shoulder and Elbow Surgeons score for estimating shoulder function was based on a score from 0 to 100, where 0 indicated poor outcome and 100 indicated excellent outcome.
Greater tuberosity bone mineral density
Time frame: preoperatively
GT BMD was measured using the predefined region of interest (ROI). Dividing the humeral head into three columns of even width, we defined a 1x1-cm2-sized square in the center of the lateral column as ROI.
Lumbar spine bone mineral density
Time frame: preoperatively
Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
Hip bone mineral density
Time frame: preoperatively
Measured by using standard techniques according to the manufacturer and the International Society for Clinical Densitometry guidelines.
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 19 Oct 2020.
- Background: PubMed 24388151Oh JH, Song BW, Lee YS. Measurement of volumetric bone mineral density in proximal humerus using quantitative computed tomography in patients with unilateral rotator cuff tear. J Shoulder Elbow Surg. 2014 Jul;23(7):993-1002. doi: 10.1016/j.jse.2013.09.024. Epub 2013 Dec 31.
- Background: PubMed 25027108Oh JH, Song BW, Kim SH, Choi JA, Lee JW, Chung SW, Rhie TY. The measurement of bone mineral density of bilateral proximal humeri using DXA in patients with unilateral rotator cuff tear. Osteoporos Int. 2014 Nov;25(11):2639-48. doi: 10.1007/s00198-014-2795-1. Epub 2014 Jul 16.
- Background: PubMed 31805019Pogorzelski J, Fritz EM, Horan MP, Katthagen JC, Hussain ZB, Godin JA, Millett PJ. Minimum Five-year Outcomes and Clinical Survivorship for Arthroscopic Transosseous-equivalent Double-row Rotator Cuff Repair. J Am Acad Orthop Surg. 2019 Dec 15;27(24):e1093-e1101. doi: 10.5435/JAAOS-D-18-00519.
- Background: PubMed 27357383Ono Y, Woodmass JM, Nelson AA, Boorman RS, Thornton GM, Lo IK. Knotless anchors with sutures external to the anchor body may be at risk for suture cutting through osteopenic bone. Bone Joint Res. 2016 Jun;5(6):269-75. doi: 10.1302/2046-3758.56.2000535.
- Derived from this study: PubMed 33581302Lee S, Hwang JT, Lee SS, Lee JH, Kim TY. Greater Tuberosity Bone Mineral Density and Rotator Cuff Tear Size Are Independent Factors Associated With Cutting-Through in Arthroscopic Suture-Bridge Rotator Cuff Repair. Arthroscopy. 2021 Jul;37(7):2077-2086. doi: 10.1016/j.arthro.2021.01.059. Epub 2021 Feb 10.
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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.
Jung-Taek Hwang, MD, PhD principal investigator
Chuncheon Sacred Heart Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Chuncheon Sacred Heart Hospital.
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 3 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 19 Oct 2020. 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?
The occurrence of cutting-through (time frame: During the surgery). The study lists 6 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 NCT04587180, which also lists 5 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 19 Oct 2020.