Clinical trial NCT04258605: ASHCOM Shoulder System and Its Related Instruments
Official title: ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rotator Cuff Injuries
Shoulder Pain
Arthropathy; Traumatic
Arthroplasty Complications
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival of Implant System (Kaplan Meier)
timeFrame: 3 years
Secondary outcomes:
measure: The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM)
timeFrame: Pre-operative (baseline), 1 year, 2 years post-operative
measure: Oxford Shoulder Score (OSS)
timeFrame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
measure: EQ-5D-5L Score
timeFrame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
measure: Subjective Shoulder Value (SSV)
timeFrame: Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative
measure: Radiographic Parameters
timeFrame: 2 years post-operative
Other outcomes:
Locations:
city: Ragusa
country: Italy
facility: Clinica del Mediterraneo
Study officials:
affiliation: Clinica del Mediterraneo
name: Marcello Stamilla, MD
role: PRINCIPAL_INVESTIGATOR
References: