Osteoarthritis, Hip
Conditions
Brief summary
The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.
Interventions
DEVICEDELTA-ST cup in combination with MINIMA stem
Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.
Sponsors
Limacorporate S.p.a
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards * Both genders * Any race * A diagnosis in the target hip of one or more of the following: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis 2. Rheumatoid Arthritis 3. Post-traumatic arthritis 4. Fractures of femoral neck 5. Congenital or acquired deformity * Patient willingness to participate
Exclusion criteria
* Local or systemic infection * 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 (for example due to osteoporosis) 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 * Required revision of previous standard femoral stem * Age \< 18 years old * Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to: 1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery 2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device 3. known metabolic disorders leading to progressive bone deterioration * Hip replacement on the contralateral side performed within less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | Pre-operative - Month 36 | Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability assessment of DELTA ST-C cup | At discharge - Month 36 | Radiographic analysis and stability assessment of the DELTA ST-C cup as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up |
| Stability assessment of MINIMA stem | At discharge - Month 36 | Radiographic analysis and stability assessment of the MINIMA stem as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up |
| Survival rate of the implant | Month 36 | The survival rate of the implant is expressed by Kaplan-Meier estimator |
| Safety assessment (adverse events) | Intra-operative - Month 36 | Assessment of any possible adverse device event or device-related complication detected and recorded |
Countries
Greece
Contacts
Primary ContactFabiana Pavan
Backup ContactFederica Azzimonti
Outcome results
None listed