Clinical trial NCT03312465: Anatomical Shoulder Domelock System Study
Official title: Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Avascular Necrosis
Revision Surgery
Conditions Consequent to Earlier Operations
Arthritis, Rheumatoid
Arthritis, Degenerative
Arthritis;Traumatic
Keywords: Total Shoulder Arthroplasty
Hemi Shoulder Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Implant Survivorship
timeFrame: 10 Years
Secondary outcomes:
measure: Clinical Performance
timeFrame: 5 Years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Daun
country: Germany
facility: Krankenhaus Maria Hilf
city: Hamburg
country: Germany
facility: HELIOS ENDO-Klinik Hamburg
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: Univeritätklinik Bagrist
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
Study officials:
affiliation: Zimmer Biomet Clinical Operations
name: Emilie Rohmer
role: STUDY_DIRECTOR
References: