Osteoarthritis
Conditions
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.
Interventions
DEVICEU-Motion II+ Acetabular System
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
Sponsors
United Orthopedic Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be considered for inclusion in the study. 1. Subject is between 18 and 75 years of age 2. Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device 3. Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip 4. Subject is willing and able to provide informed consent to participate in the study; 5. 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;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Operative Time | Procedure | Operative time in minutes |
| 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). |
| 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 |
| 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 |
| Estimated Blood Loss (EBL) | 2 Years | Estimated blood loss in cc's |
Countries
United States
Outcome results
None listed