Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

NCT04520087 | Recruiting

• 1 other identifier: J-Plasty
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Shoulder Dislocation; Bone Defects; Shoulder Instability

Keywords

Implant-Free Shoulder Instability; Bone Grafting; Shoulder Instability; Glenoid; allograft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in DASH score

  Baseline, 1, 3, 6, and 12 months

• Change from Baseline in Constant score

  Baseline, 1, 3, 6, 12 and 24 months

• Change from Baseline in Rowe score

  Baseline, 1, 3, 6, 12 and 24 months

• Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:

  Baseline, 1, 3, 6, 12 and 24 months

• Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring

  24 months

Study Arms (1)

allograft fixation

EXPERIMENTAL

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

Interventions

allograft fixation PROCEDURE

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.

Also known as: bone grafting for shoulder instability

allograft fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• antero.inferior shoulder instability with bone loss

You may not qualify if:

• Patients incapable of understanding or wanting;
• Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Enrico Guerra, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Andreani

CONTACT

0516366072; daniele.andreani@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot study

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 20, 2020
• Study Start: October 13, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

IT (1)