Rotator Cuff TearNCT01039571
Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair. Our null hypothesis is there are no differences in clinical and structural results Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- double row repair
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to Jan 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rotator cuff tear patients
Who may be able to join
- Rotator cuff tears
- tear size between 2cm~4cm
Who cannot join
- Subscapularis tear requiring repair
- open repair
- any prior history of surgery on the affected shoulder
- any fracture history around shoulder girdle(clavicle, humerus, acromion)
- glenohumeral joint arthritis
- inflammatory arthropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Case-controlled Blinded Study of Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
The purpose of this study is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair.
Our null hypothesis is there are no differences in clinical and structural results
- Conditions
- Rotator Cuff Tear
- Being tested
- double row repair
- Keywords
- rotator cuff tear, arthroscopic repair, single row repair, double row repair, retear rate
- 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.
double row repairProcedure or surgery
Also called dual row repair
double row repair for torn rotator cuff were performed to compare with the conventional single row repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Retear rate in each group(single row repair group and double row repair group)
Measured: MRI after 6 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039571
- Sponsor's protocol ID
- 2005-12-005
- Status last verified
- Apr 2011
- First submitted
- 23 Dec 2009
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Grasso A, Milano G, Salvatore M, Falcone G, Deriu L, Fabbriciani C. Single-row versus double-row arthroscopic rotator cuff repair: a prospective randomized clinical study. Arthroscopy. 2009 Jan;25(1):4-12. doi: 10.1016/j.arthro.2008.09.018. Epub 2008 Nov 1.
PubMed 19111212Burks RT, Crim J, Brown N, Fink B, Greis PE. A prospective randomized clinical trial comparing arthroscopic single- and double-row rotator cuff repair: magnetic resonance imaging and early clinical evaluation. Am J Sports Med. 2009 Apr;37(4):674-82. doi: 10.1177/0363546508328115. Epub 2009 Feb 9.
PubMed 19204365Franceschi F, Ruzzini L, Longo UG, Martina FM, Zobel BB, Maffulli N, Denaro V. Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: a randomized controlled trial. Am J Sports Med. 2007 Aug;35(8):1254-60. doi: 10.1177/0363546507302218. Epub 2007 Jun 6.
PubMed 17554104Charousset C, Grimberg J, Duranthon LD, Bellaiche L, Petrover D. Can a double-row anchorage technique improve tendon healing in arthroscopic rotator cuff repair?: A prospective, nonrandomized, comparative study of double-row and single-row anchorage techniques with computed tomographic arthrography tendon healing assessment. Am J Sports Med. 2007 Aug;35(8):1247-53. doi: 10.1177/0363546507301661. Epub 2007 Apr 23.
PubMed 17452513Mazzocca AD, Millett PJ, Guanche CA, Santangelo SA, Arciero RA. Arthroscopic single-row versus double-row suture anchor rotator cuff repair. Am J Sports Med. 2005 Dec;33(12):1861-8. doi: 10.1177/0363546505279575. Epub 2005 Oct 6.
PubMed 16210578Park JY, Lhee SH, Choi JH, Park HK, Yu JW, Seo JB. Comparison of the clinical outcomes of single- and double-row repairs in rotator cuff tears. Am J Sports Med. 2008 Jul;36(7):1310-6. doi: 10.1177/0363546508315039. Epub 2008 Apr 15.
PubMed 18413680
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Case-controlled Blinded Study of Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT01039571
- Acronym / sponsor ID
- 2005-12-005
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, arthroscopic repair, single row repair, double row repair, retear rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Dec 2009 (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 is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair.
Our null hypothesis is there are no differences in clinical and structural results
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rotator cuff tear patients
Key inclusion criteria (2 listed)
- Rotator cuff tears
- tear size between 2cm~4cm
Key exclusion criteria (6 listed)
- Subscapularis tear requiring repair
- open repair
- any prior history of surgery on the affected shoulder
- any fracture history around shoulder girdle(clavicle, humerus, acromion)
- glenohumeral joint arthritis
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 |
|---|---|---|
| double row repairAlso: dual row repairdouble row repair for torn rotator cuff were performed to compare with the conventional single row repair | Procedure or surgery | – |
Primary outcome
Retear rate in each group(single row repair group and double row repair group)
Time frame: MRI after 6 months from 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 22 Apr 2011.
- Background: PubMed 19111212Grasso A, Milano G, Salvatore M, Falcone G, Deriu L, Fabbriciani C. Single-row versus double-row arthroscopic rotator cuff repair: a prospective randomized clinical study. Arthroscopy. 2009 Jan;25(1):4-12. doi: 10.1016/j.arthro.2008.09.018. Epub 2008 Nov 1.
- Background: PubMed 19204365Burks RT, Crim J, Brown N, Fink B, Greis PE. A prospective randomized clinical trial comparing arthroscopic single- and double-row rotator cuff repair: magnetic resonance imaging and early clinical evaluation. Am J Sports Med. 2009 Apr;37(4):674-82. doi: 10.1177/0363546508328115. Epub 2009 Feb 9.
- Background: PubMed 17554104Franceschi F, Ruzzini L, Longo UG, Martina FM, Zobel BB, Maffulli N, Denaro V. Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: a randomized controlled trial. Am J Sports Med. 2007 Aug;35(8):1254-60. doi: 10.1177/0363546507302218. Epub 2007 Jun 6.
- Background: PubMed 17452513Charousset C, Grimberg J, Duranthon LD, Bellaiche L, Petrover D. Can a double-row anchorage technique improve tendon healing in arthroscopic rotator cuff repair?: A prospective, nonrandomized, comparative study of double-row and single-row anchorage techniques with computed tomographic arthrography tendon healing assessment. Am J Sports Med. 2007 Aug;35(8):1247-53. doi: 10.1177/0363546507301661. Epub 2007 Apr 23.
- Background: PubMed 16210578Mazzocca AD, Millett PJ, Guanche CA, Santangelo SA, Arciero RA. Arthroscopic single-row versus double-row suture anchor rotator cuff repair. Am J Sports Med. 2005 Dec;33(12):1861-8. doi: 10.1177/0363546505279575. Epub 2005 Oct 6.
- Background: PubMed 18413680Park JY, Lhee SH, Choi JH, Park HK, Yu JW, Seo JB. Comparison of the clinical outcomes of single- and double-row repairs in rotator cuff tears. Am J Sports Med. 2008 Jul;36(7):1310-6. doi: 10.1177/0363546508315039. Epub 2008 Apr 15.
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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?
An observational study of Rotator Cuff Tear, 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 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 22 Apr 2011. 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?
Retear rate in each group(single row repair group and double row repair group) (time frame: MRI after 6 months from 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 NCT01039571, which also lists 6 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 22 Apr 2011.