LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study

Study Overview
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Brief Summary
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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.

Official Title
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LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Clinical Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: LFIT™ Femoral Heads With X3® Insert


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LFIT™Femoral Heads With X3® Insert<br>LFIT™ Femoral Heads With X3® Insert | Device: LFIT™ Femoral Heads With X3® Insert<br>* LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear Wear Rate | Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period. . | 5 Years Post-Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor | preoperative, 1, 3, and 5 years | 
| Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits | This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it. Pain: None or ignores it = 44 points Slight, occasional, no compromise in activities = 40 points Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points Marked pain, serious limitation of activities = 10 points Totally disabled, crippled, pain in bed, bedridden = 0 points | preop, 1, 3, and 5 Years | 
| Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. | This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome. Flexion: 0-45 degrees x 1.0 index value = max 45 points 45-90 degrees x 0.6 index = max 27 points 90-110 degrees x 0.3 index = max 6 points 110-130 degrees = max 0 points Abduction: 0-15 degrees x 0.8 index = max 12 points 15-20 degrees x 0.3 index = max 1.5 points 20-45 degrees x 0 index = max 0 points External Rotation in extension: 0-15 degrees x 0.4 index = max 6 points Over 15 degrees = max 0 points Internal Rotation in extension: Any = max 0 points Adduction: 0-15 degrees x 0.2 index = max 3 points Over 15 degrees - max 0 points To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05. | preoperative, 1, 3, and 5 Years | 
| Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. | The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being. It includes a physical component score and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | preop, 1, 3, and 5 Years | 
| Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores. The LEAS completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | preoperative, 1, 3, and 5 Years | 
| Number of Hips That Dislocated | The number of hips that experienced a hip dislocation. | 3 and 5 years | 
| Number of Hips Evaluated as Radiographically Unstable | Radiographic instability is defined as having any of the following findings on x-ray: Radiographic indication of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component Radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component Radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component Radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm. | 1, 3, 5 years | 
| Percentage of Cases That Did Not Have Any Component Revised | A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner. The 97.42% estimate is obtained by Kaplan-Meier method. | 5 years |