Clinical trial NCT02761499: Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem
Official title: Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Lead sponsor: United Orthopedic Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Operative Success
timeFrame: 2 Years
Secondary outcomes:
measure: Operative Time
timeFrame: Procedure
measure: VAS Hip Pain
timeFrame: Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
measure: Device Related Adverse Events
timeFrame: Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
measure: Length of hospital stay
timeFrame: 2 Years
measure: Estimated Blood Loss (EBL)
timeFrame: 2 Years
measure: HOOS Questionnaire
timeFrame: Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
measure: Subject Satisfaction
timeFrame: Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
measure: Harris Hip Score
timeFrame: Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville Orthopaedic Institute
state: Florida
city: Naples
country: United States
facility: Joint Replacement Institute
state: Florida
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Dayton
country: United States
facility: Ortho Dayton
state: Ohio
city: Philadelphia
country: United States
facility: Penn Orthopaedics
state: Pennsylvania
city: Kenosha
country: United States
facility: Kenosha Orthopedics
state: Wisconsin
Study officials:
affiliation: HSS
name: Edwin Su, MD
role: PRINCIPAL_INVESTIGATOR
References: