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

Stryker Orthopaedics89 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthroplasty, Replacement, Hip

Interventions

LFIT™ Femoral Heads With X3® InsertDEVICE

LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned. 2. Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger. 3. 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 4. Patient is a male or non-pregnant female age 18 years or older at time of enrollment. 5. Patient has signed an IRB approved, study specific Informed Patient Consent Form. 6. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: 1. Patient has an active infection within the affected hip joint. 2. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint. 3. Patient has a Body Mass Index (BMI) ≥ 40. 4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 5. 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). 6. Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day. 7. Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule. 8. Patient is a prisoner.

Locations (5)

Cedars Medical Center University of Miami

Miami, Florida, United States

Tufts Medical Center

Boston, Massachusetts, United States

Seaview Orthopedics

Ocean City, New Jersey, United States

The Center: Orthopedic & Neurosurgical Care & Research

Bend, Oregon, United States

Outcomes

Primary Outcomes

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. .

Time frame: 5 Years Post-Surgery

Secondary Outcomes

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

Time frame: 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: 1. None or ignores it = 44 points 2. Slight, occasional, no compromise in activities = 40 points 3. Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points 4. 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 5. Marked pain, serious limitation of activities = 10 points 6. Totally disabled, crippled, pain in bed, bedridden = 0 points

Time frame: 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.

Data from ClinicalTrials.gov

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