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

NCT ID: NCT04823455

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2021-04-30

Brief Summary

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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

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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

Conditions

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Shoulder Dislocation Closed Traumatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Diagnosis of an acute non-reducible posterior gleno-humeral 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34496807 (View on PubMed)

Other Identifiers

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ALLO-OMERO

Identifier Type: -

Identifier Source: org_study_id

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