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

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ClinicalTrials.gov Identifier: NCT02761499
Recruitment Status : Active, not recruiting
First Posted : May 4, 2016
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Device: U-Motion II+ Acetabular System

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Operative Time [ Time Frame: Procedure ]
    Operative time in minutes

  2. 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

  3. 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.

  4. Length of hospital stay [ Time Frame: 2 Years ]
    Length of stay in hours or days

  5. Estimated Blood Loss (EBL) [ Time Frame: 2 Years ]
    Estimated blood loss in cc's

  6. 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).

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects presenting with a documented history with chronic hip pain and disability due to degenerative joint disease such as osteoarthritis.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Ortho Dayton
Dayton, Ohio, United States, 45415
United States, Pennsylvania
Penn Orthopaedics
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Kenosha Orthopedics
Kenosha, Wisconsin, United States, 53143
Sponsors and Collaborators
United Orthopedic Corporation
Investigators
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Principal Investigator: Edwin Su, MD HSS
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Responsible Party: United Orthopedic Corporation
ClinicalTrials.gov Identifier: NCT02761499    
Other Study ID Numbers: 01-2015
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases