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

Primary Purpose

Shoulder Dislocation Closed Traumatic

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation Closed Traumatic focused on measuring shoulder dislocation, humeral allograft, locked posterior dislocation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allo Omero 2020

Arm Description

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.

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability index (WOSI)
The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
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.
Constant-Murley score (CS)
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

Samilson-Prieto score
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.

Full Information

First Posted
March 29, 2021
Last Updated
March 30, 2022
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04823455
Brief Title
Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion
Acronym
ALLO-OMERO2020
Official Title
Results Following Fresh-frozen Humeral Head Osteochondral Allograft Reconstruction for Reverse Hill-Sachs Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation Closed Traumatic
Keywords
shoulder dislocation, humeral allograft, locked posterior dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allo Omero 2020
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario Shoulder Instability index (WOSI)
Description
The WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems
Time Frame
2 months
Title
American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Description
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.
Time Frame
2 months
Title
Constant-Murley score (CS)
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Samilson-Prieto score
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Maria Marcheggiani Muccioli, MD, PhD
Phone
+39 051 6366509
Email
marcheggianimuccioli@me.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34496807
Citation
Marcheggiani Muccioli GM, Rinaldi VG, Lullini G, Ritali A, Mosca M, Romagnoli M, Guerra E, Zaffagnini S. Mid-Term outcomes following fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill Sachs lesion: a case series. BMC Musculoskelet Disord. 2021 Sep 8;22(1):768. doi: 10.1186/s12891-021-04657-z.
Results Reference
derived

Learn more about this trial

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

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