Acute Fracture, Arthritis, Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Replacement, post-traumatic arthritis
Brief summary
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.
Detailed description
The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.
Interventions
DEVICEAcetabular cup
Acetabular cup replacement
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Primary hip replacement * Sufficient bone stock to support implant * Signed Informed Patient Consent form
Exclusion criteria
* Prior renal transplant * History of active joint sepsis * Recent high dose of corticosteroids * Primary or secondary carcinoma in the last 5 years * Neurological disease * Psychosocial disease that would limit rehabilitation * Use of structural bone graft * Simultaneous participation in another hip study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survivorship | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score | Pre-operative, 6 month and 1, 2, 3, 4, and 5 years. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. |
| Short Form-36 (SF-36) | Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. |
Countries
United States
Outcome results
None listed