Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

Not Applicable

Recruiting

• Conditions: Bone Defects; Anterior Shoulder Dislocation; Shoulder Instability
• Interventions: Procedure: allograft fixation

• Registration Number: NCT04520087
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-10-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
allograft fixation	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in DASH score at 24th months	24 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

Name	Time	Method
Change from baseline in DASH score	Baseline, 1, 3, 6, and 12 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.
Change from Baseline in Constant score	Baseline, 1, 3, 6, 12 and 24 months	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	Baseline, 1, 3, 6, 12 and 24 months	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.
Evaluation of the Allograft integration	6 and 12 months	Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment
Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:	Baseline, 1, 3, 6, 12 and 24 months	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	24 months	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy