Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: U-Motion II+ Acetabular System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Hip Arthroplasty<br>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. | Device: U-Motion II+ Acetabular System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Success | Post-operative increase in Harris Hip Score of > 20 points + radiographically stable implant + no additional femoral reconstruction stable implant + no additional femoral reconstruction | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Operative time in minutes | Procedure | 
| VAS Hip Pain | Improvement in Hip Pain VAS scores out to 5 years | Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. | 
| Device Related Adverse Events | Device related adverse events will be assessed at each follow up visit. | Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. | 
| Length of hospital stay | Length of stay in hours or days | 2 Years | 
| Estimated Blood Loss (EBL) | Estimated blood loss in cc's | 2 Years | 
| HOOS Questionnaire | 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). | Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. | 
| Subject Satisfaction | To assess the subject's satisfaction with their hip implant | Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. | 
| Harris Hip Score | Assess outcome of total hip replacement | Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. |