Rotator Cuff TearsNCT04960449
Arthroscopic Treatment of Partial Rotator Cuff Tears in Shoulder Joint
An observational study of Rotator Cuff Tears, run by Peking University Third Hospital at 1 site in China.
Trial summary
A retrospective analysis was performed on patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. To evaluate functional outcomes and tendon healing after arthroscopy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- shoulder arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with partial-thickness rotator cuff tendon tears. Partial rotator cuff tears can be divided into three categories, bursa side tears, tendon tears and joint side tears. Studies have found that rotator cuff tendon tears account for 55% of partial tears, compared to the other two types of partial tears, there has been very little research on partial-thickness rotator cuff tendon tears, which has no consensus on diagnosis and treatment.
Who may be able to join
- From August 2006 to December 2011, patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery in our department and were successfully followed up.
Who cannot join
- Patients with frozen shoulder and shoulder joint instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Treatment of Partial-thickness Rotator Cuff Tendon Tears
A retrospective analysis was performed on patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. To evaluate functional outcomes and tendon healing after arthroscopy.
Read the detailed description
To study the surgical method and clinical effect of arthroscopic treatment of rotator cuff tendon tear. Retrospective analysis was performed on patients with rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder scoring scale was used to evaluate the shoulder joint at preoperative and final follow-up.
- Conditions
- Rotator Cuff Tears
- Being tested
- shoulder arthroscopy
- 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.
shoulder arthroscopyProcedure or surgery
Patients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor.
| Study group | Role | What they receive |
|---|---|---|
| patients with partial-thickness rotator cuff tendon tears | Partial rotator cuff tears can be divided into three categories, bursa side tears, tendon tears and joint side tears. Studies have found that rotator cuff tendon tears account for 55% of partial tears, compared to the other two types of partial tears, there has been very little research on partial-thickness rotator cuff tendon tears, which has no consensus on diagnosis and treatment. Receives: Procedure: shoulder arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The function of shoulder joint was analyzed 1 year after arthroscopy.
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA (University of California, Los Angeles) Shoulder Score Scale at 1 year after operation.The UCLA scale has a minimum score of 2 and a maximum score of 35. The higher the score, the better the prognosis of the patients.
Measured: 1 year after operation
The function of shoulder joint was analyzed 2 years after arthroscopy.
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA Shoulder Score Scale at 2 years after operation
Measured: 2 years after operation
The function of shoulder joint was analyzed 5 years after arthroscopy.
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA Shoulder Score Scale at 5 years after operation
Measured: 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jian xiao, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960449
- Sponsor's protocol ID
- 2014101
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment of Partial-thickness Rotator Cuff Tendon Tears
- ClinicalTrials.gov ID
- NCT04960449
- Acronym / sponsor ID
- 2014101
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Jul 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.
A retrospective analysis was performed on patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. To evaluate functional outcomes and tendon healing after arthroscopy.
Detailed description
To study the surgical method and clinical effect of arthroscopic treatment of rotator cuff tendon tear. Retrospective analysis was performed on patients with rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder scoring scale was used to evaluate the shoulder joint at preoperative and final follow-up.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with partial-thickness rotator cuff tendon tears | – | Procedure: shoulder arthroscopyPartial rotator cuff tears can be divided into three categories, bursa side tears, tendon tears and joint side tears. Studies have found that rotator cuff tendon tears account for 55% of partial tears, compared to the other two types of partial tears, there has been very little research on partial-thickness rotator cuff tendon tears, which has no consensus on diagnosis and treatment. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with partial-thickness rotator cuff tendon tears. Partial rotator cuff tears can be divided into three categories, bursa side tears, tendon tears and joint side tears. Studies have found that rotator cuff tendon tears account for 55% of partial tears, compared to the other two types of partial tears, there has been very little research on partial-thickness rotator cuff tendon tears, which has no consensus on diagnosis and treatment.
Key inclusion criteria (1 listed)
- From August 2006 to December 2011, patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery in our department and were successfully followed up.
Key exclusion criteria (1 listed)
- Patients with frozen shoulder and shoulder joint instability.
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 |
|---|---|---|
| shoulder arthroscopyPatients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor. | Procedure or surgery | patients with partial-thickness rotator cuff tendon tears |
Primary outcome
The function of shoulder joint was analyzed 1 year after arthroscopy.
Time frame: 1 year after operation
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA (University of California, Los Angeles) Shoulder Score Scale at 1 year after operation.The UCLA scale has a minimum score of 2 and a maximum score of 35. The higher the score, the better the prognosis of the patients.
The function of shoulder joint was analyzed 2 years after arthroscopy.
Time frame: 2 years after operation
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA Shoulder Score Scale at 2 years after operation
The function of shoulder joint was analyzed 5 years after arthroscopy.
Time frame: 5 years after operation
The range of motion and strength of the shoulder joint in all directions are evaluated and recorded. Analysis of UCLA Shoulder Score Scale at 5 years after operation
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 13 Jul 2021.
- 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.
jian xiao principal investigator
Peking University Third Hospital
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 Tears, run by Peking University Third Hospital 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 1 inclusion and 1 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 13 Jul 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 function of shoulder joint was analyzed 1 year after arthroscopy. (time frame: 1 year after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.