Anatomical Shoulder Domelock System Study

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03312465
• Other study ID #: CME2014-07E
• Status: Active, not recruiting
• Start date: September 28, 2017
• Est. completion date: December 31, 2033

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Arthritis, Rheumatoid
• Avascular Necrosis
• Conditions Consequent to Earlier Operations
• Necrosis
• Osteoarthritis
• Revision Surgery

Intervention

Device:
• AS Domelock System
Hemi or Total Shoulder Arthroplasty

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Germany	Krankenhaus Maria Hilf	Daun
Germany	HELIOS ENDO-Klinik Hamburg	Hamburg
Switzerland	Universitätsspital Basel	Basel
Switzerland	Univeritätklinik Bagrist	Zürich
United Kingdom	Royal Derby Hospital	Derby

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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