ASHCOM Shoulder System and Its Related Instruments

NCT04258605 | Terminated Results

• 1 other identifier: CME2017-67E
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.

Conditions

Rotator Cuff Injuries; Shoulder Pain; Arthropathy; Traumatic; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• Survival of Implant System (Kaplan Meier)

  The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years.

  3 years

Secondary Outcomes (5)

• The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)

  Pre-operative (baseline), 1 year, 2 years post-operative

• Oxford Shoulder Score (OSS)

  Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

• EQ-5D-5L Score

  Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

• Subjective Shoulder Value (SSV)

  Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative

• Radiographic Parameters

  2 years post-operative

Study Arms (1)

ASHCOM Shoulder System subjects

Subjects implanted with the ASHCOM Shoulder System

Device: ASHCOM Shoulder System

Interventions

ASHCOM Shoulder System DEVICE

Reverse Shoulder Arthroplasty

ASHCOM Shoulder System subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from severe shoulder pain and disability indicated for implantation of the ASHCOM Shoulder System and who meet all inclusion and none of the exclusion criteria.

You may qualify if:

• Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
• Patient has given written consent to take part in the study by signing the "Patient Consent Form".
• Patient is 18-80 years of age, inclusive.
• Patient is skeletally mature.
• Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
• Patient's joint is anatomically and structurally suited to receive the selected implants.
• Patient has a functional deltoid muscle.

You may not qualify if:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
• Patient is known to be pregnant or breastfeeding.
• Patient is a vulnerable subject.
• Patient meets at least one of the contraindications:
• Signs of infection
• Significant injury to the upper brachial plexus
• Non-functional deltoid muscle
• Insufficient quality and/or quantity of glenoid or humeral bone
• Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Clinica del Mediterraneo

Ragusa, 97100, Italy

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Joint Diseases

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of this study are the low overall sample size of 24 cases as well as the short follow-up period of three years.

Results Point of Contact

• Title: Carina Hafner
• Organization: Zimmer Biomet

carina.hafner@zimmerbiomet.com

+41797073093

Study Officials

• Marcello Stamilla, MD

  Clinica del Mediterraneo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: December 10, 2019
• Primary Completion: December 18, 2023
• Study Completion: August 13, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)