RECRUITING

Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, for adults who require hip resurfacing arthroplasty due to 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or 2) mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.

Official Title

A Multi-Center, Prospective, Non-Randomized, Pivotal Trial Evaluating the Safety and Effectiveness of the Polymotion Hip Resurfacing System

Quick Facts

Study Start:2025-01-22
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06792539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Steve Meakins Vice President, Quality and Regulatory Affairs
CONTACT
01905 640008
steve@jointmedica.com
Sharat Kusuma, MD
CONTACT
Sharat@jointmedica.com

Principal Investigator

Michael Mont, MD
PRINCIPAL_INVESTIGATOR
Principal Investigator

Study Locations (Sites)

Florida Medical Clinic Orlando Health
Tampa, Florida, 33613
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Sinai Hospital / LifeBridge Health
Baltimore, Maryland, 21215
United States
NYU Longone
New York, New York, 10003
United States
Joint Implant Surgeons
New Albany, Ohio, 43054
United States
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, 29210
United States
Hampton Road Orthopaedics
Newport News, Virginia, 23606
United States

Collaborators and Investigators

Sponsor: JointMedica Inc.

  • Michael Mont, MD, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-01-22
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • hip resurfacing
  • Osteoarthritis of the Hip
  • deterioration of hip cartilage
  • Polymotion

Additional Relevant MeSH Terms

  • Osteoarthritis of the Hip
  • Degenerative Joint Disease of Hip
  • Dysplasia; Hip