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

NCT00510458 | Completed Results

• 1 other identifier: 63
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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. .

  5 Years Post-Surgery

Secondary Outcomes (8)

• Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits

  preoperative, 1, 3, and 5 years

• Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits

  preop, 1, 3, and 5 Years

• Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.

  preoperative, 1, 3, and 5 Years

• Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.

  preop, 1, 3, and 5 Years

• Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative

  preoperative, 1, 3, and 5 Years

Study Arms (1)

LFIT™Femoral Heads With X3® Insert

OTHER

LFIT™ Femoral Heads With X3® Insert

Device: LFIT™ Femoral Heads With X3® Insert

Interventions

LFIT™ Femoral Heads With X3® Insert DEVICE

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

LFIT™Femoral Heads With X3® Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
• Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
• 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
• Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
• Patient has signed an IRB approved, study specific Informed Patient Consent Form.
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• Patient has an active infection within the affected hip joint.
• Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
• Patient has a Body Mass Index (BMI) ≥ 40.
• Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
• 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).
• Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
• Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
• Patient is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (5)

Cedars Medical Center University of Miami

Miami, Florida, 33136, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Seaview Orthopedics

Ocean City, New Jersey, 07712, United States

Location

The Center: Orthopedic & Neurosurgical Care & Research

Bend, Oregon, 97701, United States

Location

Greater Pittsburgh Orthopaedic Associates

Moon Township, Pennsylvania, 15108, United States

Location

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Stryker Orthopaedics

ellen.axelson@stryker.com

201-831-5401

Study Officials

• James D'Antonio, MD

  Greater Pittsburgh Orthopaedic Associates

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-01

Locations

US (5)