Rotator Cuff TearsNCT04710966
Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears
A study testing arthroscopic debridement and arthroscopic repair in people with Rotator Cuff Tears, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- arthroscopic debridement and arthroscopic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 15 Nov 2020
- 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
- Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
- Failed of conservative treatment for more than 3 months
- Intraoperative arthroscopic confirmed that the tear was Ellman grade II
Who cannot join
- Previous surgical surgery on the shoulder
- Articular-side or intratendinous rotator cuff tears
- Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
- Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
- The presence of other diseases that affect shoulder function
- Contraindication to arthroscopic surgery or anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial
The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.
Read the detailed description
This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.
- Conditions
- Rotator Cuff Tears
- Being tested
- arthroscopic debridement, arthroscopic repair
- Keywords
- partial-thickness, bursal-side tear, rotator cuff tears, arthroscopic debridement, arthroscopic 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 debridementProcedure or surgery
For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.
arthroscopic repairProcedure or surgery
For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.
| Study group | Role | What they receive |
|---|---|---|
| debridement group | Experimental | For the debridement group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic debridement will be performed. Receives: Procedure: arthroscopic debridement |
| repair group | Experimental | For the repair group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic repair will be performed. Receives: Procedure: arthroscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: Baseline
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: Postoperative 6 months
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: Postoperative 12 months
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: Postoperative 18 months
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints. Possible scores range from 0 to 100，a higher score means a better result.
Measured: Baseline
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Measured: postoperative 6 months
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Measured: postoperative 12 months
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Measured: postoperative 18 months
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: Baseline
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: postoperative 6 months
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: postoperative 12 months
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: postoperative 18 months
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: Baseline
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: postoperative 6 months
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: postoperative 12 months
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: postoperative 18 months
Secondary outcomes (3)
Grading of rotator cuff integrity
The integrity of the rotator cuff was assessed by magnetic resonance imaging (MRI) according to a grading criteria, as follows: Grade I and II, sufficient thickness with low or partial high intensity; Grade III, insufficient thickness without discontinuity; Grade IV and V, presence of a minor or major discontinuity.
Measured: 18 months after surgery
Grading of muscle atrophy
Muscular atrophy was assessed on oblique sagittal MRI images using an occupation ratio measured by dividing the supraspinatus muscle's cross-sectional area by that of the supraspinatus fossa on the oblique-sagittal view. When the ratio was between 1.00 and 0.60, the muscle was considered normal or with slight atrophy (Grade I); values between 0.60 and 0.40 indicated moderate atrophy (Grade II); values below 0.40 indicated severe atrophy (Grade III).
Measured: 18 months after surgery
Grading of fatty degeneration
Fatty degeneration in supraspinatus muscle was assessed by magnetic resonance imaging (MRI) according to a grading system with stages 0-4 as follows: grade 0, no fat; Grade 1, thin fatty streaks; Grade 2, heavy fat infiltration, with muscle still pre-dominating; Grade 3, even distribution of fat and muscle; Grade 4, more fat than muscle.
Measured: 18 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 posted15 Jan 2021
- Study start1 Sep 2017
- Primary completion31 Oct 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 The Affiliated Hospital of Qingdao UniversityThe 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
- Model description
- Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. According to preoperative allocation, the patients were given arthroscopic debridement or repair respectively.For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, we converted partial tears into full-thickness tears and sutured them
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teng Wang, Principal investigator, InvestigatorTengbo Yu, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710966
- Sponsor's protocol ID
- wangteng
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.
PubMed 2182260Chung SW, Kim JY, Yoon JP, Lyu SH, Rhee SM, Oh SB. Arthroscopic repair of partial-thickness and small full-thickness rotator cuff tears: tendon quality as a prognostic factor for repair integrity. Am J Sports Med. 2015 Mar;43(3):588-96. doi: 10.1177/0363546514561004. Epub 2014 Dec 22.
PubMed 25535097Kwon OS, Kelly JI. Outcome analysis of arthroscopic treatment of partial thickness rotator cuff tears. Indian J Orthop. 2014 Jul;48(4):385-9. doi: 10.4103/0019-5413.136249.
PubMed 25143642Strauss EJ, Salata MJ, Kercher J, Barker JU, McGill K, Bach BR Jr, Romeo AA, Verma NN. Multimedia article. The arthroscopic management of partial-thickness rotator cuff tears: a systematic review of the literature. Arthroscopy. 2011 Apr;27(4):568-80. doi: 10.1016/j.arthro.2010.09.019.
PubMed 21296545Cordasco FA, Backer M, Craig EV, Klein D, Warren RF. The partial-thickness rotator cuff tear: is acromioplasty without repair sufficient? Am J Sports Med. 2002 Mar-Apr;30(2):257-60. doi: 10.1177/03635465020300021801.
PubMed 11912097Wolff AB, Magit DP, Miller SR, Wyman J, Sethi PM. Arthroscopic fixation of bursal-sided rotator cuff tears. Arthroscopy. 2006 Nov;22(11):1247.e1-4. doi: 10.1016/j.arthro.2006.05.026.
PubMed 17084305Zhang Y, Zhai S, Qi C, Chen J, Li H, Zhao X, Yu T. A comparative study of arthroscopic debridement versus repair for Ellman grade II bursal-side partial-thickness rotator cuff tears. J Shoulder Elbow Surg. 2020 Oct;29(10):2072-2079. doi: 10.1016/j.jse.2020.03.006. Epub 2020 Jun 1.
PubMed 32499197
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04710966
- Acronym / sponsor ID
- wangteng
- Conditions
- Rotator Cuff Tears
- Keywords
- partial-thickness, bursal-side tear, rotator cuff tears, arthroscopic debridement, arthroscopic repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 15 Jan 2021 (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 conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.
Detailed description
This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. According to preoperative allocation, the patients were given arthroscopic debridement or repair respectively.For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, we converted partial tears into full-thickness tears and sutured them
| Arm | Type | Receives |
|---|---|---|
| debridement group | Experimental | Procedure: arthroscopic debridementFor the debridement group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic debridement will be performed. |
| repair group | Experimental | Procedure: arthroscopic repairFor the repair group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic repair will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
- Failed of conservative treatment for more than 3 months
- Intraoperative arthroscopic confirmed that the tear was Ellman grade II
Key exclusion criteria (6 listed)
- Previous surgical surgery on the shoulder
- Articular-side or intratendinous rotator cuff tears
- Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
- Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
- The presence of other diseases that affect shoulder function
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 debridementFor the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed. | Procedure or surgery | debridement group |
| arthroscopic repairFor the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them. | Procedure or surgery | repair group |
Primary outcome
The Visual Analog Scale score
Time frame: Baseline
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
Time frame: Postoperative 6 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
Time frame: Postoperative 12 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
Time frame: Postoperative 18 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Constant-Murray Shoulder score
Time frame: Baseline
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints. Possible scores range from 0 to 100，a higher score means a better result.
Constant-Murray Shoulder score
Time frame: postoperative 6 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Constant-Murray Shoulder score
Time frame: postoperative 12 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Constant-Murray Shoulder score
Time frame: postoperative 18 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
American Shoulder and Elbow Surgeon score
Time frame: Baseline
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
American Shoulder and Elbow Surgeon score
Time frame: postoperative 6 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
American Shoulder and Elbow Surgeon score
Time frame: postoperative 12 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
American Shoulder and Elbow Surgeon score
Time frame: postoperative 18 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
University of California-Los Angeles score
Time frame: Baseline
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
Time frame: postoperative 6 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
Time frame: postoperative 12 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
Time frame: postoperative 18 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
3 secondary outcomes
Grading of rotator cuff integrity
Time frame: 18 months after surgery
Grading of muscle atrophy
Time frame: 18 months after surgery
Grading of fatty degeneration
Time frame: 18 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 15 Jan 2021.
- Results publication: PubMed 2182260Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.
- Results publication: PubMed 25535097Chung SW, Kim JY, Yoon JP, Lyu SH, Rhee SM, Oh SB. Arthroscopic repair of partial-thickness and small full-thickness rotator cuff tears: tendon quality as a prognostic factor for repair integrity. Am J Sports Med. 2015 Mar;43(3):588-96. doi: 10.1177/0363546514561004. Epub 2014 Dec 22.
- Results publication: PubMed 25143642Kwon OS, Kelly JI. Outcome analysis of arthroscopic treatment of partial thickness rotator cuff tears. Indian J Orthop. 2014 Jul;48(4):385-9. doi: 10.4103/0019-5413.136249.
- Results publication: PubMed 21296545Strauss EJ, Salata MJ, Kercher J, Barker JU, McGill K, Bach BR Jr, Romeo AA, Verma NN. Multimedia article. The arthroscopic management of partial-thickness rotator cuff tears: a systematic review of the literature. Arthroscopy. 2011 Apr;27(4):568-80. doi: 10.1016/j.arthro.2010.09.019.
- Results publication: PubMed 11912097Cordasco FA, Backer M, Craig EV, Klein D, Warren RF. The partial-thickness rotator cuff tear: is acromioplasty without repair sufficient? Am J Sports Med. 2002 Mar-Apr;30(2):257-60. doi: 10.1177/03635465020300021801.
- Results publication: PubMed 17084305Wolff AB, Magit DP, Miller SR, Wyman J, Sethi PM. Arthroscopic fixation of bursal-sided rotator cuff tears. Arthroscopy. 2006 Nov;22(11):1247.e1-4. doi: 10.1016/j.arthro.2006.05.026.
- Results publication: PubMed 32499197Zhang Y, Zhai S, Qi C, Chen J, Li H, Zhao X, Yu T. A comparative study of arthroscopic debridement versus repair for Ellman grade II bursal-side partial-thickness rotator cuff tears. J Shoulder Elbow Surg. 2020 Oct;29(10):2072-2079. doi: 10.1016/j.jse.2020.03.006. Epub 2020 Jun 1.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Teng Wang principal investigator
Investigator
Tengbo Yu study chair
professor
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 debridement and arthroscopic repair in people with Rotator Cuff Tears, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 15 Jan 2021. 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 China. 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 Visual Analog Scale score (time frame: Baseline). The study lists 16 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 NCT04710966, which also lists 7 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 15 Jan 2021.