DELTA Multihole TT Study

University Hospital Bratislava

Status: Unknown

Conditions: Hip Osteoarthritis; Hip Dysplasia; Arthroplasty Complications

Treatments: Device: hip arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04375345

UHBratislava

Details and patient eligibility

About

A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

IInclusion criteria as per DELTA Multihole TT indications for use:

Age ≥ 18 years

• Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;
• Signed Informed consent
• Hip dislocation using protruded liners, spacers;
• Rheumatoid arthritis;
• Post-traumatic arthritis;
• Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;
• Fractures of femoral neck;

If used in combination with spacers and hemispheric modules, other indications are:

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;
• Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;
• Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.

Exclusion criteria as per DELTA Multihole TT contraindications for use:

• Local or systemic infections;
• Septicaemia;
• Persistent acute or chronic osteomyelitis;
• Confirmed nerve or muscle lesion compromising hip joint function;
• Vascular or nerve diseases affecting the concerned limb;
• Poor bone stock compromising the stability of the implant;
• Metabolic disorders which may impair fixation and stability of the implant;
• Any concomitant disease and dependence that might affect the implanted prosthesis;
• Metal hypersensitivity to implant materials.

Additional exclusion criteria:

• Female patients who are pregnant, nursing, or planning a pregnancy.