- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04823455
Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion (ALLO-OMERO2020)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40136
- IRCCS Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of an acute non-reducible posterior gleno-humeral dislocation with an associated McLaughlin lesion affecting more than 30% of the cartilaginous circumference of the humeral head.
Exclusion Criteria:
- Patients with associated injuries to the affected upper limb, with neuromuscular or psychomotor disorders or with disorders affecting connective tissues.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Allo Omero 2020
Humeral allograft group 12 patients were surgically treated for a locked posterior glenohumeral dislocation with a humeral head defect affecting at least 30% of the head diameter.
During surgery, the bone defect was substituted with a fresh-frozen humeral head osteochondral allograft.Included patients were clinically and radiographically re-evaluated for the purpose of this study by examiners not involved in the primary treatment at a mean of 66 months postoperatively.
The clinical examination consisted of a physical examination and structured interview.
Computed tomography (CT) was carried out at the medium follow-up of 66 months in all patients to evaluate OA progression and allograft resorption.
|
Between 2001 and 2018, a total of 12 consecutive patients were surgically treated for a locked posterior glenohumeral dislocation with a humeral head defect affecting at least 30% of the head diameter.
During surgery, the bone defect was substituted with a fresh-frozen humeral head osteochondral allograft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constant-Murley score (CS)
Time Frame: 2 months
|
The Constant-Murley score is a 100-points scale composed of a number of individual parameters.
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
The higher the score, the higher the quality of the function.
|
2 months
|
Western Ontario Shoulder Instability index (WOSI)
Time Frame: 2 months
|
The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Overall scores range from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. |
2 months
|
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time Frame: 2 months
|
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) was designed to assess the condition of the shoulder, regardless of disease pathology. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. 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. |
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Samilson-Prieto score
Time Frame: 2 months
|
The Samilson-Prieto classification system is based on the presence and size of osteophytes and the rate of arthrosis in the uninvolved shoulder reflects the high sensitivity of this system. The prevalence of arthritis is often reported in long-term follow-ups after trauma or surgery. The higher the score, the worse the arthritis. |
2 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALLO-OMERO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Dislocation Closed Traumatic
-
Keller Army Community HospitalRecruitingSurgery | Anterior Shoulder Dislocation | Shoulder Subluxation | Recurrent Shoulder DislocationUnited States
-
University of PittsburghWalter Reed National Military Medical CenterRecruitingShoulder Dislocation | Anterior Shoulder Dislocation | Glenohumeral DislocationUnited States
-
Artromedical Konrad Malinowski ClinicRecruitingLateral Patellofemoral Dislocation Closed Traumatic | Lateral Patellar LuxationPoland
-
University of CalgaryMemorial University of Newfoundland; Calgary Orthopaedic Research and Education...RecruitingClosed Fracture Dislocation, Tarsometatarsal Joint | Open Fracture Dislocation, Tarsometatarsal JointCanada
-
Istituto Ortopedico RizzoliRecruitingShoulder Instability | Anterior Shoulder Dislocation | Bone DefectsItaly
-
Carolyn M HettrichUniversity of Colorado, Denver; Washington University School of Medicine; University... and other collaboratorsRecruitingOther Instability, Shoulder | Dislocations | Subluxations | Recurrent Dislocation of Shoulder RegionUnited States
-
Peking University Third HospitalCompletedShoulder; Dislocation, ChronicChina
-
Copenhagen University Hospital, HvidovreCompletedAnterior Shoulder Dislocation
-
Tel-Aviv Sourasky Medical CenterUnknownAnterior Shoulder Dislocation
-
National Taiwan University HospitalUnknownShoulder Anterior DislocationTaiwan