Subchondral Fractures of the GlenoidNCT02308423
Clinical and Radiologic Follow up of Subchondral Fractures of the Glenoid
An observational study of Subchondral Fractures of the Glenoid, run by Meir Medical Center.
Trial summary
in this study the investigators will call patients who had Subchondral fractures and treated in our department over the last 20 years. The investigators will evaluate their shoulder function by a questionary, Constant score and radiologic evaluation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subchondral Fractures of the Glenoid
- What is being tested?
- XR of shoulder
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients 18-80 yo who had subchondral fractures of the glenoid
Who may be able to join
- Any man or women who had subchondral fractures of the glenoid
Who cannot join
- Pregnant women
- Children
About this study
in this study the investigators will call patients who had Subchondral fractures and treated in our department over the last 20 years.
The investigators will evaluate their shoulder function by a questionary, Constant score and radiologic evaluation.
Read the detailed description
Patient evaluation by:
- Physical examination, questionary Constant score: Pain (severe, moderate, mild, non), activity level (sleep affected/sport limitations/daily living limitations/arm positioning) and range of motion (forward flexion/lateral elevation, internal and external rotation).
- Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.
- Conditions
- Subchondral Fractures of the Glenoid
- Being tested
- XR of shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XR of shoulderRadiation
Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.
What is being measured
The primary outcome is the main question the study is designed to answer.
Function disability of the shoulder
The patients will be invited to the clinic where the investigators will examine them and define a "constant score" that takes in consideration: Pain, Activity level and Range of motion.
Measured: 20 years
Secondary outcomes (1)
Measurement of degenerative changes of the gleno-humeral joint.
The investigators will assess the status of osteoarthrosis of the gleno-humeral joint, this will be measured by the Kellgren Lawrence (0-4) and the Samilson (0-3) scores.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subchondral Fractures of the GlenoidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308423
- Sponsor's protocol ID
- 0204-14-MMC
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiologic Follow up of Subchondral Fractures of the Glenoid
- ClinicalTrials.gov ID
- NCT02308423
- Acronym / sponsor ID
- 0204-14-MMC
- Conditions
- Subchondral Fractures of the Glenoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- 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.
in this study the investigators will call patients who had Subchondral fractures and treated in our department over the last 20 years.
The investigators will evaluate their shoulder function by a questionary, Constant score and radiologic evaluation.
Detailed description
Patient evaluation by:
- Physical examination, questionary Constant score: Pain (severe, moderate, mild, non), activity level (sleep affected/sport limitations/daily living limitations/arm positioning) and range of motion (forward flexion/lateral elevation, internal and external rotation).
- Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients 18-80 yo who had subchondral fractures of the glenoid
Key inclusion criteria (1 listed)
- Any man or women who had subchondral fractures of the glenoid
Key exclusion criteria (2 listed)
- Pregnant women
- Children
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 |
|---|---|---|
| XR of shoulderRadiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score. | Radiation | – |
Primary outcome
Function disability of the shoulder
Time frame: 20 years
The patients will be invited to the clinic where the investigators will examine them and define a "constant score" that takes in consideration: Pain, Activity level and Range of motion.
1 secondary outcome
Measurement of degenerative changes of the gleno-humeral joint.
Time frame: 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Subchondral Fractures of the Glenoid, run by Meir Medical Center.
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 11 Dec 2014. 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?
Results are not available in the source record.
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?
Function disability of the shoulder (time frame: 20 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 11 Dec 2014.