Anterior Shoulder DislocationNCT04520087
Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
A study testing allograft fixation in people with Anterior Shoulder Dislocation and Bone Defects, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Shoulder Dislocation, Bone Defects, Shoulder Instability
- What is being tested?
- allograft fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 13 Oct 2020to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- antero.inferior shoulder instability with bone loss
Who cannot join
- Patients incapable of understanding or wanting;
- Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
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.
Read the detailed description
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.
- Being tested
- allograft fixation
- Keywords
- Implant-Free Shoulder Instability, Bone Grafting, Shoulder Instability, Glenoid, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allograft fixationProcedure or surgery
Also called bone grafting for shoulder instability
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.
| Study group | Role | What they receive |
|---|---|---|
| allograft fixation | Experimental | 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. Receives: Procedure: allograft fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in DASH score at 24th 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.
Measured: 24 months
Secondary outcomes (6)
Change from baseline in DASH score
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.
Measured: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Constant score
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).
Measured: Baseline, 1, 3, 6, 12 and 24 months
Change from Baseline in Rowe score
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.
Measured: Baseline, 1, 3, 6, 12 and 24 months
Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:
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.
Measured: Baseline, 1, 3, 6, 12 and 24 months
Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring
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.
Measured: 24 months
Evaluation of the Allograft integration
Radiographic signs of allograft integration through the CT-dual energy instrument at 6 and 24 month post treatment
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start13 Oct 2020
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Guerra, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520087
- Sponsor's protocol ID
- J-Plasty
- Status last verified
- May 2026
- First submitted
- 29 Jul 2020
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
- ClinicalTrials.gov ID
- NCT04520087
- Acronym / sponsor ID
- J-Plasty
- Keywords
- Implant-Free Shoulder Instability, Bone Grafting, Shoulder Instability, Glenoid, allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| allograft fixation | Experimental | Procedure: allograft fixationPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- antero.inferior shoulder instability with bone loss
Key exclusion criteria (2 listed)
- Patients incapable of understanding or wanting;
- Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allograft fixationAlso: bone grafting for shoulder instabilityPatients 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. | Procedure or surgery | allograft fixation |
Primary outcome
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.
6 secondary outcomes
Change from baseline in DASH score
Time frame: Baseline, 1, 3, 6, and 12 months
Change from Baseline in Constant score
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Change from Baseline in Rowe score
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring
Time frame: 24 months
Evaluation of the Allograft integration
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Guerra, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allograft fixation in people with Anterior Shoulder Dislocation and Bone Defects, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in DASH score at 24th months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.