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Completed

NCT Number: NCT04823455

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

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.

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Key information

Conditions

Shoulder Dislocation Closed Traumatic Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Dislocation Shoulder Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Western Ontario Shoulder Instability index (WOSI)

    Time frame: 2 months

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

    Overall scores range from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function.

  2. American Shoulder and Elbow Surgeons Shoulder Score (ASES)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Samilson-Prieto score

    Time frame: 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 arthritis is often reported in long-term follow-ups after trauma or surgery.

    The higher the score, the worse the arthritis.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: ALLO-OMERO2020

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 30, 2021
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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