Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00510458
First received: August 1, 2007
Last updated: October 28, 2016
Last verified: October 2016

August 1, 2007
October 28, 2016
April 2007
November 2016   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00510458 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
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
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Hip
Device: LFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
Intervention: Device: LFIT™ Femoral Heads With X3® Insert
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
November 2016
November 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510458
63
No
Not Provided
Not Provided
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
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
Stryker Orthopaedics
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP