Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatment lfit™ femoral heads with x3® insert
Sponsor Stryker Orthopaedics
Start date April 2007
End date September 2016
Trial size 96 participants
Trial identifier NCT00510458, 63

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
LFIT™ Femoral Heads With X3® Insert
lfit™ femoral heads with x3® insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Primary Outcomes

Measure
Linear Wear Rates
time frame: 5 Years Post-Surgery

Secondary Outcomes

Measure
Harris Hip Score (HHS) score change from preop to postop intervals
time frame: preop, 1, 3, and 5 Years
HHS pain score change from preop to postop intervals
time frame: preop, 1, 3, and 5 Years
HHS ROM change from preop status to postop intervals
time frame: preop, 1, 3, and 5 Years
SF-12 Health Survey score (physical and mental) change from preop to postop intervals
time frame: preop, 1, 3, and 5 Years
Lower Extremity Activity Scale score change from preop to postop intervals
time frame: preop, 1, 3, and 5 Years
Dislocation rates
time frame: 3 and 5 years
Radiographic Stability rates
time frame: 1, 3, 5 years
Percentage of cases which did not have any component revised
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Stephen Thomas, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Stryker Orthopaedics.