Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem (U-Move)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02761499|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2016
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment|
|Osteoarthritis||Device: U-Motion II+ Acetabular System|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2025|
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.
Device: U-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
- Operative Success [ Time Frame: 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
- Operative Time [ Time Frame: Procedure ]Operative time in minutes
- VAS Hip Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 Years ]Length of stay in hours or days
- Estimated Blood Loss (EBL) [ Time Frame: 2 Years ]Estimated blood loss in cc's
- HOOS Questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761499
|United States, Florida|
|Jacksonville Orthopaedic Institute|
|Jacksonville, Florida, United States, 32204|
|Joint Replacement Institute|
|Naples, Florida, United States, 34108|
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|United States, Ohio|
|Dayton, Ohio, United States, 45415|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Wisconsin|
|Kenosha, Wisconsin, United States, 53143|
|Principal Investigator:||Edwin Su, MD||HSS|