Bone FractureProsthesisNCT03577678
New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle
A study testing Surgery to fix lateral half prosthesis for clavicle in people with Bone Fracture and Bone Lesion, run by Cairo University at 1 site in Egypt.
Trial summary
This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Bone Fracture, Bone Lesion, Clavicle Fracture
- What is being tested?
- Surgery to fix lateral half prosthesis for clavicle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2018to 18 Nov 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female has right lateral part comminuted fracture clavicle .
Who cannot join
- Male patient
- Cancer bone patient.
- Pregnant
- Left lateral part comminuted fracture clavicle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comminuted Lateral Half Fracture of Clavicle is Most Common and at This Case Report Study the Investigators Introduce a New Prophesies for This Fracture
This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.
Read the detailed description
. Lateral clavicle fracture lead to sever pain and affect on shoulder movement . This prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain.
This prosthesis will reconstruct the missed part of the clavicle.
- Conditions
- Bone Fracture, Bone Lesion, Clavicle Fracture
- Being tested
- Surgery to fix lateral half prosthesis for clavicle
- Keywords
- Comminuted lateral clavicle fracture , New prosthesis,
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery to fix lateral half prosthesis for clavicleProcedure or surgery
Also called surgery
Surgery to fix lateral half prosthesis for clavicle
| Study group | Role | What they receive |
|---|---|---|
| observational | Experimental | orthopaedic Surgery to fix lateral half prosthesis for clavicle Receives: Procedure: Surgery to fix lateral half prosthesis for clavicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scan
CT scan to determine the status and position of the prosthesis
Measured: 1 Day
Secondary outcomes (3)
CT scan
CT scan to determine the status and position of the prosthesis
Measured: 6 month
Pain intensity measurements: Visual analogue scale
Visual analogue scale from 0 to 10 , 0 is no pain and 10 unbearable pain
Measured: 6 month
American shoulder and elbow surgeons score Special Score for shoulder pain and function.
The American shoulder and elbow surgeons score is a composite instrument, requiring both a physician assessment and a patient-completed portion.
. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Intensity of pain: 0; Putting on a coat is not difficult; Sleeping on the affected side is not difficult; Washing my back/doing up my bra is not difficult; Managing toiletting is not difficult; Combing my hair is not difficult; Reaching a high shelf is not difficult; Lifting 10lbs. (4.5kg) above my shoulder is not difficult; Throwing a ball overhand is not difficult; Doing my usual work is not difficult; Doing my usual sport/leisure activity is not difficult; It means good shoulder.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start5 Aug 2018
- Primary completion1 Sep 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Surgery was made to fix the new prosthesis
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Ahmed Abdalbary, Cairo University
- Investigators
- Sahar A Abdalbary, ph.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577678
- Sponsor's protocol ID
- Cairo University Hospital
- Acronym
- Prosthesis
- Status last verified
- Aug 2021
- First submitted
- 13 Jun 2018
- Last updated
- 3 Aug 2021
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comminuted Lateral Half Fracture of Clavicle is Most Common and at This Case Report Study the Investigators Introduce a New Prophesies for This Fracture
- ClinicalTrials.gov ID
- NCT03577678
- Acronym / sponsor ID
- Prosthesis / Cairo University Hospital
- Conditions
- Bone Fracture, Bone Lesion, Clavicle Fracture
- Keywords
- Comminuted lateral clavicle fracture , New prosthesis,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 5 Jul 2018 (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.
This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.
Detailed description
. Lateral clavicle fracture lead to sever pain and affect on shoulder movement . This prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain.
This prosthesis will reconstruct the missed part of the clavicle.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Surgery was made to fix the new prosthesis
| Arm | Type | Receives |
|---|---|---|
| observational | Experimental | Procedure: Surgery to fix lateral half prosthesis for clavicleorthopaedic Surgery to fix lateral half prosthesis for clavicle |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female has right lateral part comminuted fracture clavicle .
Key exclusion criteria (4 listed)
- Male patient
- Cancer bone patient.
- Pregnant
- Left lateral part comminuted fracture clavicle
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 |
|---|---|---|
| Surgery to fix lateral half prosthesis for clavicleAlso: surgerySurgery to fix lateral half prosthesis for clavicle | Procedure or surgery | observational |
Primary outcome
CT scan
Time frame: 1 Day
CT scan to determine the status and position of the prosthesis
3 secondary outcomes
CT scan
Time frame: 6 month
Pain intensity measurements: Visual analogue scale
Time frame: 6 month
American shoulder and elbow surgeons score Special Score for shoulder pain and function.
Time frame: 6 month
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 3 Aug 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.
Sahar A Abdalbary, ph.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery to fix lateral half prosthesis for clavicle in people with Bone Fracture and Bone Lesion, run by Cairo 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 4 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 3 Aug 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 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?
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?
CT scan (time frame: 1 Day). 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 3 Aug 2021.