Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem
- Conditions
- Osteoarthritis
- Interventions
- Device: U-Motion II+ Acetabular System
- Registration Number
- NCT02761499
- Lead Sponsor
- United Orthopedic Corporation
- Brief Summary
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.
- Detailed Description
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem. The acetabular and femoral components will be uncemented. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
It is anticipated that up to 200 subjects will be enrolled at up to 5 sites. The subjects will be evaluated at predetermined intervals: baseline, procedure/ discharge and 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually up to 5 years for device survivorship. The estimated study duration from first enrollment through completion of the final report is expected to be approximately 7 years.
This study will be conducted at up to 5 investigational sites in the United States with previous clinical research experience and with adequate population of orthopedic patients requiring primary total hip arthroplasty.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Subjects must meet all of the following criteria to be considered for inclusion in the study.
- Subject is between 18 and 75 years of age
- Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device
- Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip
- Subject is willing and able to provide informed consent to participate in the study;
- Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
- Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Total Hip Arthroplasty U-Motion II+ Acetabular System The United Hip System consist of several components, and for this clinical evaluation it includes the U-Motion II+ Acetabular System (1) U-Motion II+ acetabular cup, (2) U-Motion II+ acetabular liner, (3) Cobalt-Chrome or BIOLOX delta ceramic femoral heads, and the 4) UTF Reduced Stem.
- Primary Outcome Measures
Name Time Method Operative Success 2 Years Post-operative increase in Harris Hip Score of \> 20 points + radiographically stable implant + no additional femoral reconstruction stable implant + no additional femoral reconstruction
- Secondary Outcome Measures
Name Time Method Operative Time Procedure Operative time in minutes
Subject Satisfaction Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. To assess the subject's satisfaction with their hip implant
VAS Hip Pain Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. Improvement in Hip Pain VAS scores out to 5 years
Device Related Adverse Events Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. Device related adverse events will be assessed at each follow up visit.
Length of hospital stay 2 Years Length of stay in hours or days
Estimated Blood Loss (EBL) 2 Years Estimated blood loss in cc's
HOOS Questionnaire Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. To assess patient-relevant outcomes in five separate subscales (pain, symptoms, activity of daily living, sport and recreation function and hip related quality of life).
Harris Hip Score Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. Assess outcome of total hip replacement
Trial Locations
- Locations (6)
Kenosha Orthopedics
🇺🇸Kenosha, Wisconsin, United States
Jacksonville Orthopaedic Institute
🇺🇸Jacksonville, Florida, United States
Joint Replacement Institute
🇺🇸Naples, Florida, United States
Penn Orthopaedics
🇺🇸Philadelphia, Pennsylvania, United States
Ortho Dayton
🇺🇸Dayton, Ohio, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States