NCT03312465

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
80mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Sep 2017Dec 2032

Study Start

First participant enrolled

September 28, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2032

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

15.2 years

First QC Date

October 12, 2017

Last Update Submit

March 20, 2026

Conditions

Arthritis, DegenerativeArthritis;TraumaticAvascular NecrosisRevision SurgeryConditions Consequent to Earlier OperationsArthritis, Rheumatoid

Keywords

Total Shoulder ArthroplastyHemi Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical Performance

    5 Years

Study Arms (1)

AS Domelock System Subjects

Subjects that receive the Anatomical Shoulder Domelock System

Device: AS Domelock System

Interventions

AS Domelock SystemDEVICE

Hemi or Total Shoulder Arthroplasty

AS Domelock System Subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Krankenhaus Maria Hilf

Daun, Germany

Location

HELIOS ENDO-Klinik Hamburg

Hamburg, Germany

Location

Univeritätklinik Bagrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Universitätsspital Basel

Basel, Switzerland

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

OsteonecrosisArthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Emilie Rohmer

    Zimmer Biomet Clinical Operations

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

September 28, 2017

Primary Completion (Estimated)

December 9, 2032

Study Completion (Estimated)

December 9, 2032

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

CH(2)GB(1)DE(2)BE(1)