N/A
Completed N=221
Trident® X3 Polyethylene Insert Study
Arthroplasty, Replacement, Hip
Source: ClinicalTrials.gov NCT00958191 ↗
Enrolled (actual)
221
Serious AEs
9.8%
Results posted
Jul 2014
Primary outcomePrimary: Mean Linear Wear Rate at 5 Years — 0.016 mm/year
Summary
The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Linear Wear Rate at 5 Years |
0.016 | — |
| PRIMARY Rate of Incidence of Revision of Component for Any Reason |
4.84 | — |
| SECONDARY Linear Wear Rate of the Trident X3 Polyethylene Insert |
0.022; 0.024 | — |
| SECONDARY Volumetric Wear Rate of the Trident X3 Polyethylene Insert |
17.9; 19.1; 13.3 | — |
| SECONDARY Radiographic Stability |
0; 0; 0; 0; 0 | — |
| SECONDARY Mean Harris Hip Score (HHS) to Assess Change |
53.01; 94.41; 95.32; 94.05 | <0.0001 sig |
| SECONDARY Mean Harris Hip Score (HHS) Pain Score to Assess Change |
16.73; 41.52; 42.50; 41.75 | <0.0001 sig |
| SECONDARY Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change |
3.90; 4.99; 4.99; 4.93 | <0.0001 sig |
| SECONDARY Mean SF-12 Health Survey Score to Assess Change |
32.11; 49.90; 49.97; 49.08; 53.75; 55.72 | <0.0001 sig |
| SECONDARY Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change |
8.95; 11.65; 11.69; 10.92 | <0.0001 sig |
| SECONDARY Implant Survivorship |
95.79; 98.37 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
- The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
- The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
- The patient is a male or non-pregnant female patient ages 21 to 75.
- The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
- The patient has an active infection with the affected hip joint.
- The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- The patient has a BMI >45.
- The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- The patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00958191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.