Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Instability; Anterior Shoulder Dislocation; Bone Defects
• Intervention / Treatment: Procedure: allograft fixation

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniele Andreani; Phone Number: 0516366072; Email: daniele.andreani@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Daniele Andreani, M.Sc.
    • Principal Investigator: Enrico Guerra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: bone grafting for shoulder instability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Enrico Guerra, MD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: allograft; Glenoid; Bone Grafting; Shoulder Instability; Implant-Free Shoulder Instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: J-Plasty

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No