A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
1 other identifier
observational
149
1 country
5
Brief Summary
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2006
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2006
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2016
CompletedMarch 30, 2020
March 1, 2020
10 years
June 13, 2008
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of revisions and removals
Patient questionnaire
Annually through 10 years
Study Arms (1)
ArComXL® polyethylene
ArComXL® polyethylene
Eligibility Criteria
Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene
You may qualify if:
- Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of Functional Deformity
- Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
- Uncemented applications
You may not qualify if:
- Absolute contraindications
- Infection, sepsis and osteomyelitis
- Relative contraindications
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may be spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (5)
The Orthopaedic Center
Rockville, Maryland, 20850, United States
The Orthopaedic Institute of Ohio
Lima, Ohio, 45804, United States
Ohio Valley Orthopedic and Sports Medicine
West Chester, Ohio, 45069, United States
Scranton Orthopaedic Specialists, PC
Dickson City, Pennsylvania, 18519, United States
Texas Orthopedic Specialists, PA
Grapevine, Texas, 76051, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kacy Arnold, MBA
Zimmer Biomet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
January 23, 2006
Primary Completion
January 15, 2016
Study Completion
January 15, 2016
Last Updated
March 30, 2020
Record last verified: 2020-03