N/A
N=74
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT00510458 ↗Enrolled (actual)
74
Serious AEs
2.6%
Results posted
Mar 2018
Primary outcome: Primary: Linear Wear Rate — 0.008 mm/year
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LFIT™ Femoral Heads With X3® Insert (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linear Wear Rate |
0.008 | — |
| SECONDARY Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits |
51.03; 94.14; 97.98; 97.59 | <0.0001 sig |
| SECONDARY Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits |
15.77; 41.36; 43.39; 42.89 | <0.0001 sig |
| SECONDARY Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. |
4.05; 5.00; 4.98; 5.00 | <0.0001 sig |
| SECONDARY Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. |
34.8; 49.93; 52.51; 50.35; 50.75; 55.63 | <0.0001 sig |
| SECONDARY Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative |
9.41; 11.76; 12.56; 12.33 | <0.0001 sig |
| SECONDARY Number of Hips That Dislocated |
0; 0 | — |
| SECONDARY Number of Hips Evaluated as Radiographically Unstable |
0; 0; 0 | — |
| SECONDARY Percentage of Cases That Did Not Have Any Component Revised |
97.42 | — |
Summary
Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.
Eligibility Criteria
Inclusion Criteria
- Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
- Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
- Patient has 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
- Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
- Patient has an active infection within the affected hip joint.
- Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis).
- Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- Patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00510458). 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.