LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study (LFIT)
|ClinicalTrials.gov Identifier: NCT00510458|
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment|
|Arthroplasty, Replacement, Hip||Device: LFIT™ Femoral Heads With X3® Insert|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2007|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
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
- Linear Wear Rate [ Time Frame: 5 Years Post-Surgery ]
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.
- Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits [ Time Frame: preoperative, 1, 3, and 5 years ]
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
- Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits [ Time Frame: preop, 1, 3, and 5 Years ]
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.
- 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
- Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits. [ Time Frame: preoperative, 1, 3, and 5 Years ]
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.
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
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
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.
- Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals. [ Time Frame: preop, 1, 3, and 5 Years ]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.
- Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative [ Time Frame: preoperative, 1, 3, and 5 Years ]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.
- Number of Hips That Dislocated [ Time Frame: 3 and 5 years ]The number of hips that experienced a hip dislocation.
- Number of Hips Evaluated as Radiographically Unstable [ Time Frame: 1, 3, 5 years ]
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.
- Percentage of Cases That Did Not Have Any Component Revised [ Time Frame: 5 years ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 City, 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, 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|