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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02308423
Other study ID # 0204-14-MMC
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 24, 2014
Last updated December 10, 2014
Start date January 2015
Est. completion date March 2016

Study information

Verified date November 2014
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 12
Est. completion date March 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Any man or women who had subchondral fractures of the glenoid

Exclusion Criteria:

- Pregnant women

- Children

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Radiation:
XR of shoulder
Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 years No
Secondary 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. 20 years No