ASHCOM Shoulder System and Its Related Instruments

ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study

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.

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Injuries; Shoulder Pain; Arthroplasty Complications; Arthropathy; Traumatic
• Intervention / Treatment: Device: ASHCOM Shoulder System

Detailed Description

This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.

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. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Italy
  • Ragusa, Italy, 97100
    • Clinica del Mediterraneo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASHCOM Shoulder System subjects; Subjects implanted with the ASHCOM Shoulder System	Device: ASHCOM Shoulder System; Reverse Shoulder Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)	The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).	Pre-operative (baseline), 1 year, 2 years post-operative
Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19.	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
EQ-5D-5L Score	The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst.	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Subjective Shoulder Value (SSV)	The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal.	Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
Radiographic Parameters	Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching	2 years post-operative

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Marcello Stamilla, MD, Clinica del Mediterraneo

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): August 13, 2024

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Rupture; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: CME2017-67E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No