Anatomical Shoulder Domelock System Study

Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study

The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis, Rheumatoid; Avascular Necrosis; Arthritis, Degenerative; Revision Surgery; Conditions Consequent to Earlier Operations; Arthritis;Traumatic
• Intervention / Treatment: Device: AS Domelock System

Detailed Description

This study is a multicenter, prospective and retrospective, non-controlled PMCF study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. A minimum of six study centers will be involved and a total number of 73 implants will be included into the study.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

• Study Contact: Name: Carina Hafner; Phone Number: +41 79 707 30 93; Email: carina.hafner@zimmerbiomet.com
• Study Contact Backup: Name: Lisa To; Phone Number: +32 479 97 05 43; Email: Lisa.To@zimmerbiomet.com

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitaire Ziekenhuizen Leuven
• Germany
  • Daun, Germany
    • Krankenhaus Maria Hilf
  • Hamburg, Germany
    • HELIOS ENDO-Klinik Hamburg
• Switzerland
  • Basel, Switzerland
    • Universitätsspital Basel
  • Zürich, Switzerland, 8008
    • Univeritätklinik Bagrist
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 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 Anatomical Shoulder Domelock System in hemi or total shoulder arthroplasty and who meet all inclusion and none of the exclusion criteria.

Description

Inclusion Criteria:

• Patient is 18-80 years of age, inclusive
• Patient is skeletally mature
• Patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral HSA or TSA based on physical exam and medical history
• Patient has failed conservative treatment

• Patient meets at least one of the following indications:

  • Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
  • Avascular necrosis
  • Conditions consequent to earlier operations
  • Optional use in revision: in some medical conditions (e.g., early revision when adequate bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Additional criteria for retrospective patients:

• patient has been implanted with the Domelock system before site initiation visit.
• information available must include at minimum demographic information, the operative report and details of the device implanted.

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 meets at least one of the contraindications:

  • Patient's physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant, e.g., previous surgery, insufficient quality or quantity of bone, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention e.g., absence of musculoligamentous supporting structures, joint neuropathy or other conditions that may lead to inadequate skeletal fixation
  • Signs of infection
  • Severe instability secondary to advanced loss of osteochondral structure
  • Charcot's shoulder (neuroarthropathy)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AS Domelock System Subjects; Subjects that receive the Anatomical Shoulder Domelock System	Device: AS Domelock System; Hemi or Total Shoulder Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	The primary endpoint of this study 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.	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance	The secondary endpoint is defined by the performance of the Anatomical Shoulder Domelock System at 5 years, which is assessed by the Constant and Murley score. 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.	5 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Clinical Operations Director Zimmer Biomet EMEA

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Total Shoulder Arthroplasty; Hemi Shoulder Arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Necrosis
• Other Study ID Numbers: CME2014-07E

Drug and device information, study documents

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