LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Linear Wear Rates [ Time Frame: 5 Years Post-Surgery ] [ Designated as safety issue: No ]To evaluate the linear wear rates of X3® polyethylene inserts mated with LFIT™ Anatomic CoCr Femoral Heads at 5 years postoperative. It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems.
- Harris Hip Score (HHS) score change from preop to postop intervals [ Time Frame: preop, 1, 3, and 5 Years ] [ Designated as safety issue: No ]The Harris Hip Score (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
- HHS pain score change from preop to postop intervals [ Time Frame: preop, 1, 3, and 5 Years ] [ Designated as safety issue: No ]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.
- HHS ROM change from preop status to postop intervals [ Time Frame: preop, 1, 3, and 5 Years ] [ Designated as safety issue: No ]This subscore of the overall HHS includes the total points for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction) into one subscore of a maximimun of 5.025 points which equals more range of motion.
- SF-12 Health Survey score (physical and mental) change from preop to postop intervals [ Time Frame: preop, 1, 3, and 5 Years ] [ Designated as safety issue: No ]The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ragning from 0-100. Low values represent a poor health state and high values represent a good health state.
- Lower Extremity Activity Scale score change from preop to postop intervals [ Time Frame: preop, 1, 3, and 5 Years ] [ Designated as safety issue: No ]The LEAS is 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.
- Dislocation rates [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
- Radiographic Stability rates [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: Yes ]
Radiographic stability is defined as having all of the following:
- No radiographic indications of progressive radiolucent lines ≥ 2 mm in thickness around the entire acetabular component
- No radiographic indication of migration of ≥ 3 mm or ≥ 5° of the acetabular component
- No radiographic indication of progressive radiolucent lines ≥ 2 mm thickness around the entire femoral component
- No radiographic indication of progressive subsidence of the femoral component of ≥ 5 mm.
- Percentage of cases which did not have any component revised [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Active Comparator: LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
Device: LFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510458
|United States, Florida|
|Cedars Medical Center University of Miami|
|Miami, Florida, United States, 33136|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, New Jersey|
|Ocean, New Jersey, United States, 07712|
|United States, Oregon|
|The Center: Orthopedic & Neurosurgical Care & Research|
|Bend, Oregon, United States, 97701|
|United States, Pennsylvania|
|Greater Pittsburgh Orthopaedic Associates|
|Moon Township, Pennsylvania, United States, 15108|
|Study Chair:||James D'Antonio, MD||Greater Pittsburgh Orthopaedic Associates|
|Principal Investigator:||Stephen Thomas, M.D.||Greater Pittsburgh Orthopaedic Associates|
|Principal Investigator:||Eric Smith, M.D.||Tufts University Medical Center|
|Principal Investigator:||Arthur Mark, M.D.||Seaview Orthopaedic|