Clinical trial NCT00565786: ArCom® and ArComXL® Polyethylene Data Collection
Official title: A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients requiring total hip replacement.

Brief summary: The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.

Detailed description: The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.

Eligibility criteria: Inclusion Criteria:

* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision of previously failed total hip arthroplasty

Exclusion Criteria:

* Infection
* Sepsis
* Osteomyelitis

Primary outcomes:
measure: Polyethylene wear rates
timeFrame: 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Secondary outcomes:
measure: Pain, Function, Absence of Deformity, and Range of Motion
timeFrame: Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
measure: Physical Activity Level
timeFrame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Other outcomes:
measure: Adverse Event
timeFrame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
measure: Survivorship
timeFrame: Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Locations:
city: New Albany
country: United States
facility: Joint Implant Surgeons, Inc.
state: Ohio
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Oshkosh
country: United States
facility: The Kennedy Center for the Hip & Knee
state: Wisconsin
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, MBA
role: STUDY_DIRECTOR
References: