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

Prospective Post Approval Clinical Follow-Up Study of the Commercially Available 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Jacksonville Orthopaedic Institute
    • Naples, Florida, United States, 34108
      • Joint Replacement Institute
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Ortho Dayton
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Orthopaedics
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53143
      • Kenosha Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: United Orthopedic Corporation
• Investigators: Principal Investigator: Edwin Su, MD, HSS

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimated): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 01-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED