ALLO-OMERO2020: Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Recruiting
CT.gov ID
NCT04823455
Collaborator
(none)
12
1
1
26
0.5

Study Details

Study Description

Brief Summary

Locked posterior glenohumeral dislocations with a reverse Hill-Sachs impaction fracture involving less than 30% of the humeral head are most frequently treated with lesser tuberosity transfer into the defect, whereas those involving more than 50% undergo humeral head arthroplasty. Reconstruction of the defect with segmental femoral osteochondral allografts has been proposed to treat patients between these two ranges, but the medium-/long-term outcomes of this joint-preserving procedure are controversial.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion
N/A

Detailed Description

Twelve patients with a unilateral locked posterior shoulder dislocation and at least 30% (mean 31%) impaction of the humeral head were treated with segmental reconstruction of the defect with fresh-frozen humeral head osteochondral allografts. Patients were assessed clinically, radiographically and with computed tomography (CT) at a medium follow-up of 66 months (range, 24-225).All twelve shoulders presented a slight limitation in anterior elevation

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion
Actual Study Start Date :
Jun 5, 2020
Actual Primary Completion Date :
Aug 5, 2020
Anticipated Study Completion Date :
Aug 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Allo Omero 2020

Humeral allograft group 12 patients were surgically treated for a locked posterior glenohumeral dislocation with a humeral head defect affecting at least 30% of the head diameter. During surgery, the bone defect was substituted with a fresh-frozen humeral head osteochondral allograft.Included patients were clinically and radiographically re-evaluated for the purpose of this study by examiners not involved in the primary treatment at a mean of 66 months postoperatively. The clinical examination consisted of a physical examination and structured interview. Computed tomography (CT) was carried out at the medium follow-up of 66 months in all patients to evaluate OA progression and allograft resorption.

Procedure: fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion
Between 2001 and 2018, a total of 12 consecutive patients were surgically treated for a locked posterior glenohumeral dislocation with a humeral head defect affecting at least 30% of the head diameter. During surgery, the bone defect was substituted with a fresh-frozen humeral head osteochondral allograft.

Outcome Measures

Primary Outcome Measures

  1. Western Ontario Shoulder Instability index (WOSI) [2 months]

    The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems

  2. American Shoulder and Elbow Surgeons Shoulder Score (ASES) [2 months]

    the American Shoulder and Elbow Surgeons Shoulder Score (ASES) was designed to assess the condition of the shoulder, regardless of disease pathology. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

  3. Constant-Murley score (CS) [2 months]

    The Constant-Murley score is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Secondary Outcome Measures

  1. Samilson-Prieto score [2 months]

    The Samilson-Prieto classification system is based on the presence and size of osteophytes and the rate of arthrosis in the uninvolved shoulder reflects the high sensitivity of this system. The prevalence of arthrosis is often reported in long-term follow-ups after trauma or surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

-Diagnosis of an acute nonreducible posterior glenohumeral dislocation with an associated McLaughlin lesion affecting more than 30% of the cartilaginous circumference of the humeral head.

Exclusion Criteria:

-Patients with associated injuries to the affected upper limb, with neuromuscular or psychomotor disorders or with disorders affecting connective tissues.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Istituto Ortopedico Rizzoli Bologna Italy 40136

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giulio Maria Marcheggiani Muccioli, MD, PhD, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT04823455
Other Study ID Numbers:
  • ALLO-OMERO
First Posted:
Mar 30, 2021
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giulio Maria Marcheggiani Muccioli, MD, PhD, Istituto Ortopedico Rizzoli
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022