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NCT Number: NCT04520087

Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

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.

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Key information

Conditions

Anterior Shoulder Dislocation Bone Defects Shoulder Instability

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

Patients will be informed about the study and potential risks. All patients giving written informed consent will undergo a screening visit to assess the eligibility criteria.

Patients who meet the eligibility requirements will perform a pre-treatment visit in order to assess their healthy state. Also, patients will undergo to the radiographic visit (RX and TX) as request by clinical practice.

All the patients will be treated with arthrotomy mini-open technique with bone allograft at the site of the shoulder lesion.

After surgery all the patients will be followed up to 24 months through clinical and radiographic visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • antero.inferior shoulder instability with bone loss

Exclusion criteria

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

Treatment and study plan

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.

Other names: bone grafting for shoulder instability

Primary outcomes

  1. Change from Baseline in DASH score at 24th months

    Time frame: 24 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.

Secondary outcomes

  1. Change from baseline in DASH score

    Time frame: Baseline, 1, 3, 6, and 12 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.

  2. Change from Baseline in Constant score

    Time frame: Baseline, 1, 3, 6, 12 and 24 months

    The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability).

  3. Change from Baseline in Rowe score

    Time frame: Baseline, 1, 3, 6, 12 and 24 months

    The Rowe score is a 3-item physician completed instrument. Its questions address the categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and 0-50 points indicating a poor evaluation.

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

    Time frame: Baseline, 1, 3, 6, 12 and 24 months

    EQ-5D is a standardized instrument for measuring generic health status. The classification system defines health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension with three levels ("no problems" [level 1], "some problems" [level 2], and "extreme problems" [level 3]), resulting in a total of 243 (3^5) health states. The 3L classification system defined the 243 health states by combining different levels from each dimension, with 11111 and 33333 representing full health and worst health, respectively.

  5. Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring

    Time frame: 24 months

    The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA).

    The K-L system defines OA in 5 grades:

    grade 0 (none): definite absence of x-ray changes of osteoarthritis grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping grade 2 (minimal): definite osteophytes and possible joint space narrowing grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.

  6. Evaluation of the Allograft integration

    Time frame: 6 and 12 months

    Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2020
Registry last updated
May 22, 2026

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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