Greater Tuberosity FractureNCT06603428
Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone
A study testing internal fixation by plate or screws in people with Greater Tuberosity Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Greater Tuberosity Fracture
- What is being tested?
- internal fixation by plate or screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 30 Oct 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-history of traumatic isolated GT fracture.
Who cannot join
- 1- associated proximal humeral fracture.
- 2 - previous shoulder pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone: (cohort Study)
Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.
Read the detailed description
Fractures of the greater tuberosity (GT) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. Only 14-20% of proximal humerus fractures are isolated lesions of the GT. Up to 30% of these fractures are associated with anterior glenohumeral dislocations. According to Neer, a displacement of the fragment >5mm and 30°, or >3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. However, indication for all other fractures had managed by nonoperative treatment is unclear. Currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in GT humerus fractures. The fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. Furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.
- Conditions
- Greater Tuberosity Fracture
- Being tested
- internal fixation by plate or screws
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal fixation by plate or screwsDevice
Also called arthroscopic fixation of avulsion greater tuberosity fracture
- Patients more than 5 ml displacement of GT fracture (3ml in active highly demanded patient) are for internal fixation, others less this are for conservative management.
| Study group | Role | What they receive |
|---|---|---|
| Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone. | Experimental | Patients more than 5 ml displacement of GT fracture (3ml in active highly demanded patient) are for internal fixation, others less this are for conservative management. Receives: Device: internal fixation by plate or screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score for functional outcomes
A-Pain (/15): Average(1+2) A
- Do you have pain in your shoulder (normal activities)? No =15 pts,Mild pain =10 pts,Moderate =5 pts,Severe or permanent =0.
- Linear scale:
If "0" means no pain and "15" is the maximum pain you can experience, please circle where is the level of pain of your shoulder.(Points given are inverse to the scale.E.g. level 5 in the scale means 10 points) B- Activities of daily living (/20) Total (1 + 2) B
- Is your occupation or daily living limited by your shoulder? No=4,Moderate limitation =2,Severe limitation=0
- Are your leisure and recreational activities limited by your shoulder? No=4,Moderate limitation = 2,Severe limitation=0 C.- Range of movement (leave this for the doctor or physiotherapist) (/40):Total (1 + 2 ) C
1.- FWD Flexion: 0-30 0 pts 2-Abduction: 0-30 D.- Power (/25): Points: average (kg) x 2= D
First pull:Second pull:Third pull:Fourth pull:Fifth pull:
Average pulls:
TOTA
Measured: follow up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Greater Tuberosity FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Zaghloul Thabet, Assiut University
- Investigators
- Kerolos Z Thabet, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603428
- Sponsor's protocol ID
- greater tuberosity fracture
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For conservative cases * 1ist 4 weeks abduction sling. * 2end 2 weeks active assisted movement + abduction sling. * After 6 weeks active movement. For operative cases * Day one passive movement. * After 4 weeks active assisted movement. * After 6 weeks active movement
Publications
Schliemann B, Heilmann LF, Raschke MJ, Lill H, Katthagen JC, Ellwein A. Isolated fractures of the greater tuberosity: When are they treated conservatively?: A baseline study. Obere Extrem. 2018;13(2):106-111. doi: 10.1007/s11678-018-0459-z. Epub 2018 May 15.
PubMed 29887916
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome in Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone: (cohort Study)
- ClinicalTrials.gov ID
- NCT06603428
- Acronym / sponsor ID
- greater tuberosity fracture
- Conditions
- Greater Tuberosity Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.
Detailed description
Fractures of the greater tuberosity (GT) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. Only 14-20% of proximal humerus fractures are isolated lesions of the GT. Up to 30% of these fractures are associated with anterior glenohumeral dislocations. According to Neer, a displacement of the fragment >5mm and 30°, or >3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. However, indication for all other fractures had managed by nonoperative treatment is unclear. Currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in GT humerus fractures. The fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. Furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone. | Experimental | Device: internal fixation by plate or screwsPatients more than 5 ml displacement of GT fracture (3ml in active highly demanded patient) are for internal fixation, others less this are for conservative management. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-history of traumatic isolated GT fracture.
Key exclusion criteria (2 listed)
- 1- associated proximal humeral fracture.
- 2 - previous shoulder pathology.
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 |
|---|---|---|
| internal fixation by plate or screwsAlso: arthroscopic fixation of avulsion greater tuberosity fracture- Patients more than 5 ml displacement of GT fracture (3ml in active highly demanded patient) are for internal fixation, others less this are for conservative management. | Device | Operative and Nonoperative Management in Isolated Greater Tuberosity Fracture of Humerus Bone. |
Primary outcome
Constant score for functional outcomes
Time frame: follow up 1 year
A-Pain (/15): Average(1+2) A 1. Do you have pain in your shoulder (normal activities)? No =15 pts,Mild pain =10 pts,Moderate =5 pts,Severe or permanent =0. 2. Linear scale: If "0" means no pain and "15" is the maximum pain you can experience, please circle where is the level of pain of your shoulder.(Points given are inverse to the scale.E.g. level 5 in the scale means 10 points) B- Activities of daily living (/20) Total (1 + 2) B 1. Is your occupation or daily living limited by your shoulder? No=4,Moderate limitation =2,Severe limitation=0 2. Are your leisure and recreational activities limited by your shoulder? No=4,Moderate limitation = 2,Severe limitation=0 C.- Range of movement (leave this for the doctor or physiotherapist) (/40):Total (1 + 2 ) C 1.- FWD Flexion: 0-30 0 pts 2-Abduction: 0-30 D.- Power (/25): Points: average (kg) x 2= D First pull:Second pull:Third pull:Fourth pull:Fifth pull: Average pulls: TOTA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29887916Schliemann B, Heilmann LF, Raschke MJ, Lill H, Katthagen JC, Ellwein A. Isolated fractures of the greater tuberosity: When are they treated conservatively?: A baseline study. Obere Extrem. 2018;13(2):106-111. doi: 10.1007/s11678-018-0459-z. Epub 2018 May 15.
- Individual participant dataSharing planned: Yes. For conservative cases * 1ist 4 weeks abduction sling. * 2end 2 weeks active assisted movement + abduction sling. * After 6 weeks active movement. For operative cases * Day one passive movement. * After 4 weeks active assisted movement. * After 6 weeks active movement
Related trials for Greater Tuberosity Fracture
Not yet recruiting
Displaced Greater Tuberosity Fractures With Rotator Cuff Injury
Greater Tuberosity Fracture, Rotator Cuff
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.
Kerolos Z Thabet, master principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal fixation by plate or screws in people with Greater Tuberosity Fracture, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerolos Z Thabet, master (01096271767, KerolosZaghloul@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score for functional outcomes (time frame: follow up 1 year). 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 NCT06603428, which also lists 1 linked publication.
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 Sep 2024.