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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Arthroplasty | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-Motion II+ Acetabular System | Device | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be considered for inclusion in the study.
Exclusion Criteria:
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Subjects presenting with a documented history with chronic hip pain and disability due to degenerative joint disease such as osteoarthritis.
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| Name | Affiliation | Role |
|---|---|---|
| Edwin Su, MD | HSS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Orthopaedic Institute | Jacksonville | Florida | 32204 | United States | ||
| Joint Replacement Institute |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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. |
| Naples |
| Florida |
| 34108 |
| United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Ortho Dayton | Dayton | Ohio | 45415 | United States |
| Penn Orthopaedics | Philadelphia | Pennsylvania | 19104 | United States |
| Kenosha Orthopedics | Kenosha | Wisconsin | 53143 | United States |