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

Osteoarthritis Clinical Trial

— U-Move  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02761499
• Other study ID #: 01-2015
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: August 2025

Study information

• Verified date: June 2023
• Source: United Orthopedic Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Ortho Dayton	Dayton	Ohio
United States	Jacksonville Orthopaedic Institute	Jacksonville	Florida
United States	Kenosha Orthopedics	Kenosha	Wisconsin
United States	Joint Replacement Institute	Naples	Florida
United States	Hospital for Special Surgery	New York	New York
United States	Penn Orthopaedics	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
United Orthopedic Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative Time	Operative time in minutes	Procedure
Secondary	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.
Secondary	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.
Secondary	Length of hospital stay	Length of stay in hours or days	2 Years
Secondary	Estimated Blood Loss (EBL)	Estimated blood loss in cc's	2 Years
Secondary	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.
Secondary	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.
Secondary	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.