Treatment Adherence and ComplianceNCT05261308
Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture
A study testing new prosthesis in people with Treatment Adherence and Compliance, run by Cairo University at 2 sites in Egypt.
Trial summary
Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Treatment Adherence and Compliance
- What is being tested?
- new prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Mar 2018to 18 Apr 2022
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- fracture midshaft clavicle
Who cannot join
- normal clavicle
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Sahar Abdalbary
Cairo, Select State/province, 11431
Sahar
Cairo, 11431
About this study
Official title: New Polyamide Prosthesis for Treatment of Non-union Mid Shaft Clavicle Fracture: A Case Report
Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis.
Read the detailed description
we made surgery to fix the new polyamide prosthesies in the clavicle.
- Conditions
- Treatment Adherence and Compliance
- Being tested
- new prosthesis
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new prosthesisOther
Operation to fix the new prosthesis
| Study group | Role | What they receive |
|---|---|---|
| prosthesis | Experimental | The polyamide prosthesis Receives: Other: new prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
American shoulder and elbow surgeons score Special Score for shoulder pain and function
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: after 2 and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start16 Mar 2018
- Primary completion14 Aug 2019
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Adherence and ComplianceStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 Abdalbary, professor, Principal investigator, Nahda University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261308
- Sponsor's protocol ID
- polyamide
- Status last verified
- Sep 2022
- First submitted
- 4 Feb 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share all the documents related to the case.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Polyamide Prosthesis for Treatment of Non-union Mid Shaft Clavicle Fracture: A Case Report
- ClinicalTrials.gov ID
- NCT05261308
- Acronym / sponsor ID
- polyamide
- Conditions
- Treatment Adherence and Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 2 Mar 2022 (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.
Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis.
Detailed description
we made surgery to fix the new polyamide prosthesies in the clavicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prosthesis | Experimental | Other: new prosthesisThe polyamide prosthesis |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- fracture midshaft clavicle
Key exclusion criteria (1 listed)
- normal 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 |
|---|---|---|
| new prosthesisOperation to fix the new prosthesis | Other | prosthesis |
Primary outcome
American shoulder and elbow surgeons score Special Score for shoulder pain and function
Time frame: after 2 and half years
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
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 14 Sep 2022.
- Individual participant dataSharing planned: Yes. I will share all the documents related to the case.
Related trials for Treatment Adherence and Compliance
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
Recruiting
Designing a Large Language Model Architecture for Shared Decision Making and Informed Intentions
Shared Decision Making, Health Literacy
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 Abdalbary, professor principal investigator
Nahda University, Faculty of Physical Therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new prosthesis in people with Treatment Adherence and Compliance, run by Cairo University at 2 sites 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 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
American shoulder and elbow surgeons score Special Score for shoulder pain and function (time frame: after 2 and half years). 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 14 Sep 2022.