Greater Tuberosity FractureNCT07503691
Displaced Greater Tuberosity Fractures With Rotator Cuff Injury
A study testing Arthroscopic surgery in people with Greater Tuberosity Fracture and Rotator Cuff, run by Guo Jialiang.
Trial summary
Study Type: Prospective, three-arm parallel randomized controlled trial (RCT) Study Objective: To compare the 12-month/5 years/10years functional outcomes, morphological healing, cost-effectiveness, and complication rates of three treatment strategies for displaced greater tuberosity (GT) fractures with rotator cuff… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Greater Tuberosity Fracture, Rotator Cuff
- What is being tested?
- Arthroscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age 18-76 years, male or female;
- Diagnosed with displaced GT fracture (displacement distance ≥1mm) combined with rotator cuff injury (partial tear or full-thickness tear) by computed tomography (CT) or magnetic resonance imaging (MRI);
- Time from fracture to admission ≤72 hours (acute phase);
- No severe heart, liver, kidney or other underlying diseases, and able to cooperate with 12-month complete follow-up;
- Signed informed consent and voluntarily participated in the trial.
Who cannot join
- • Pathological fracture or old fracture (>3 weeks);
- Complicated with shoulder dislocation or other proximal humeral fractures;
- Previous shoulder surgery history, rheumatoid arthritis, or severe osteoporosis;
- Mental illness, cognitive impairment, unable to complete functional scoring;
- Poor follow-up compliance, expected to be unable to complete 12-month follow-up.
About this study
Official title: Three-Arm Randomized Controlled Trial Comparing Conservative Treatment, Primary Surgery, and Delayed Surgery for Displaced Greater Tuberosity Fractures With Rotator Cuff Injury
Study Type: Prospective, three-arm parallel randomized controlled trial (RCT) Study Objective: To compare the 12-month/5 years/10years functional outcomes, morphological healing, cost-effectiveness, and complication rates of three treatment strategies for displaced greater tuberosity (GT) fractures with rotator cuff injury, and to optimize the individualized treatment strategy for GT fractures.
Study Setting: multicenter clinical trial, conducted in the Department of Orthopedics.
Study Period: April 2026 -April 2036.
- Conditions
- Greater Tuberosity Fracture, Rotator Cuff
- Being tested
- Arthroscopic surgery
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic surgeryProcedure or surgery
Also called rehabilitation in CG group, arthroscopic sugery in PG and DG group
Conservative Treatment Group (CG): rehabilitation only ; Primary Surgery Group (PG): surgery early; Delayed Surgery Group (DG): surgery late
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment Group (CG) | No intervention | no operation |
| Primary Surgery Group (PG) | Experimental | operation immediately Receives: Procedure: Arthroscopic surgery |
| Delayed Surgery Group (DG) | Experimental | operation after 3 months Receives: Procedure: Arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms.
Measured: Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Tuberosity FractureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guo Jialiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guo Jialiang, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503691
- Sponsor's protocol ID
- GJL003
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Arm Randomized Controlled Trial Comparing Conservative Treatment, Primary Surgery, and Delayed Surgery for Displaced Greater Tuberosity Fractures With Rotator Cuff Injury
- ClinicalTrials.gov ID
- NCT07503691
- Acronym / sponsor ID
- GJL003
- Conditions
- Greater Tuberosity Fracture, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guo JialiangUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 31 Mar 2026 (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.
Study Type: Prospective, three-arm parallel randomized controlled trial (RCT) Study Objective: To compare the 12-month/5 years/10years functional outcomes, morphological healing, cost-effectiveness, and complication rates of three treatment strategies for displaced greater tuberosity (GT) fractures with rotator cuff injury, and to optimize the individualized treatment strategy for GT fractures.
Study Setting: multicenter clinical trial, conducted in the Department of Orthopedics.
Study Period: April 2026 -April 2036.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment Group (CG) | No intervention | –no operation |
| Primary Surgery Group (PG) | Experimental | Procedure: Arthroscopic surgeryoperation immediately |
| Delayed Surgery Group (DG) | Experimental | Procedure: Arthroscopic surgeryoperation after 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age 18-76 years, male or female;
Key exclusion criteria (5 listed)
- • Pathological fracture or old fracture (>3 weeks);
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 surgeryAlso: rehabilitation in CG group, arthroscopic sugery in PG and DG groupConservative Treatment Group (CG): rehabilitation only ; Primary Surgery Group (PG): surgery early; Delayed Surgery Group (DG): surgery late | Procedure or surgery | Delayed Surgery Group (DG), Primary Surgery Group (PG) |
Primary outcome
SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms.
Time frame: Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic surgery in people with Greater Tuberosity Fracture and Rotator Cuff, run by Guo Jialiang.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms. (time frame: Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months). 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 31 Mar 2026.