Status:
UNKNOWN
DELTA Multihole TT Study
Lead Sponsor:
University Hospital Bratislava
Conditions:
Hip Osteoarthritis
Arthroplasty Complications
Eligibility:
All Genders
18+ years
Brief Summary
A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 23 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04375345
Start Date
January 23 2020
End Date
March 23 2022
Last Update
May 5 2020
Active Locations (1)
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1
2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine
Bratislava, Slovakia, 85107