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

NCT02761499 | Unknown

• 1 other identifier: 01-2015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Operative Time

  Procedure

• VAS Hip Pain

  Baseline, Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.

• Device Related Adverse Events

  Procedure, 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.

• Length of hospital stay

  2 Years

• Estimated Blood Loss (EBL)

  2 Years

Study Arms (1)

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

Interventions

U-Motion II+ Acetabular System DEVICE

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

Total Hip Arthroplasty

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is between 18 and 75 years of age
• Subject is indicated for a unilateral or bilateral total hip arthroplasty (THA) based on the approved labeling of the device
• Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative hip
• Subject is willing and able to provide informed consent to participate in the study;
• 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;

Sponsors & Collaborators

• United Orthopedic Corporation: lead

Study Sites (6)

Jacksonville Orthopaedic Institute

Jacksonville, Florida, 32204, United States

Location

Joint Replacement Institute

Naples, Florida, 34108, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Ortho Dayton

Dayton, Ohio, 45415, United States

Location

Penn Orthopaedics

Philadelphia, Pennsylvania, 19104, United States

Location

Kenosha Orthopedics

Kenosha, Wisconsin, 53143, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Edwin Su, MD

  HSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2025
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (6)