Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

Shoulder Instability Clinical Trial

Official title:

Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520087
• Other study ID #: J-Plasty
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Daniele Andreani
• Phone: 0516366072
• Email: daniele.andreani[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Bone Defects
• Shoulder Dislocation
• Shoulder Instability

Intervention

Procedure:
• allograft fixation
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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	Baseline, 1, 3, 6, and 12 months
Secondary	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).	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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.	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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.	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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.	24 months
Secondary	Evaluation of the Allograft integration	Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment	6 and 12 months