Arthroplasty, Replacement, Hip
Conditions
Brief summary
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.
Interventions
DEVICEOmnifit HA Hip Stem
Total Hip Replacement with Omnifit HA Hip Stem
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For use as a universal hip replacement: * Acute femoral neck fracture. * Non-union of femoral head and neck fractures. * Aseptic necrosis of the femoral head. * Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. * Salvage of failed total hip arthroplasty. For use as a total hip replacement: * Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. * Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
Exclusion criteria
* Active infection in or near the hip joint. * Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.). * Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant. * Mental disorders which would compromise essential patient post-operative care. * Skeletal immaturity. * Extreme obesity. * Significant probability that patient could not return for required follow-up evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score. | 25 Years Post-Operatively |
Countries
Netherlands, United States
Participant flow
Pre-assignment details
226 participants = 262 hips
Participants by arm
| Arm | Count |
|---|---|
| Omnifit HA Hip Stem Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem | 226 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 43 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | revision/removal | 10 |
| Overall Study | study termination | 135 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | Omnifit HA Hip Stem |
|---|---|
| Age, Continuous | 51.55 years STANDARD_DEVIATION 10.83 |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 70 / 226 |
| serious Total, serious adverse events | 104 / 226 |
Outcome results
Primary
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
Time frame: 25 Years Post-Operatively
Population: The study was closed and no subjects reached the 25 year postoperative endpoint.