Back to resultsClinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
Primary Purpose
Anterior Shoulder Dislocation, Bone Defects, Shoulder Instability
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
allograft fixation
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Shoulder Dislocation focused on measuring Implant-Free Shoulder Instability, Bone Grafting, Shoulder Instability, Glenoid, allograft
Eligibility Criteria
Inclusion Criteria:
- antero.inferior shoulder instability with bone loss
Exclusion Criteria:
- Patients incapable of understanding or wanting;
- Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
allograft fixation
Arm Description
Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.
Outcomes
Primary Outcome Measures
Change from Baseline in DASH score at 24th months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Secondary Outcome Measures
Change from baseline in DASH score
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Change from Baseline in Constant score
The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
Change from Baseline in Rowe score
The Rowe score is a 3-item physician completed instrument. Its questions address the categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and 0-50 points indicating a poor evaluation.
Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:
EQ-5D is a standardized instrument for measuring generic health status. The classification system defines health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension with three levels ("no problems" [level 1], "some problems" [level 2], and "extreme problems" [level 3]), resulting in a total of 243 (3^5) health states. The 3L classification system defined the 243 health states by combining different levels from each dimension, with 11111 and 33333 representing full health and worst health, respectively.
Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring
The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA).
The K-L system defines OA in 5 grades:
grade 0 (none): definite absence of x-ray changes of osteoarthritis grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping grade 2 (minimal): definite osteophytes and possible joint space narrowing grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.
Evaluation of the Allograft integration
Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment
Full Information
NCT ID
NCT04520087
First Posted
July 29, 2020
Last Updated
October 9, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04520087
Brief Title
Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
Official Title
Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical and radiographic results after surgical treatment with implant-free allograft in the treatment of Anterior Shoulder Dislocation and to assess the safety of the surgery.
Detailed Description
Patients will be informed about the study and potential risks. All patients giving written informed consent will undergo a screening visit to assess the eligibility criteria.
Patients who meet the eligibility requirements will perform a pre-treatment visit in order to assess their healthy state. Also, patients will undergo to the radiographic visit (RX and TX) as request by clinical practice.
All the patients will be treated with arthrotomy mini-open technique with bone allograft at the site of the shoulder lesion.
After surgery all the patients will be followed up to 24 months through clinical and radiographic visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Dislocation, Bone Defects, Shoulder Instability
Keywords
Implant-Free Shoulder Instability, Bone Grafting, Shoulder Instability, Glenoid, allograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
allograft fixation
Arm Type
Experimental
Arm Description
Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.
Intervention Type
Procedure
Intervention Name(s)
allograft fixation
Other Intervention Name(s)
bone grafting for shoulder instability
Intervention Description
Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.
Primary Outcome Measure Information:
Title
Change from Baseline in DASH score at 24th months
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change from baseline in DASH score
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Time Frame
Baseline, 1, 3, 6, and 12 months
Title
Change from Baseline in Constant score
Description
The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Change from Baseline in Rowe score
Description
The Rowe score is a 3-item physician completed instrument. Its questions address the categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and 0-50 points indicating a poor evaluation.
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:
Description
EQ-5D is a standardized instrument for measuring generic health status. The classification system defines health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension with three levels ("no problems" [level 1], "some problems" [level 2], and "extreme problems" [level 3]), resulting in a total of 243 (3^5) health states. The 3L classification system defined the 243 health states by combining different levels from each dimension, with 11111 and 33333 representing full health and worst health, respectively.
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring
Description
The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA).
The K-L system defines OA in 5 grades:
grade 0 (none): definite absence of x-ray changes of osteoarthritis grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping grade 2 (minimal): definite osteophytes and possible joint space narrowing grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.
Time Frame
24 months
Title
Evaluation of the Allograft integration
Description
Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
antero.inferior shoulder instability with bone loss
Exclusion Criteria:
Patients incapable of understanding or wanting;
Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Andreani
Phone
0516366072
Email
daniele.andreani@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Guerra, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Andreani, M.Sc.
First Name & Middle Initial & Last Name & Degree
Enrico Guerra, MD
12. IPD Sharing Statement
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Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
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