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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, subjects must meet all of the following criteria:

• Requires primary hip resurfacing arthroplasty due to:

∙ non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or

‣ mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.

• Harris Hip Score \< 70 points.

• Skeletally mature, age ≥21 and \<65 years.

• Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.

⁃ Subjects who meet any of the following criteria will be excluded from participating in this study:

• Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of \>0.45.0F

• Severe osteopenia, a medical history or increased risk of severe osteoporosis or severe osteopenia, a history of fragility fracture, and other conditions that lead to increased bone resorption

• Osteonecrosis or avascular necrosis (AVN)

• Multiple cysts of the femoral head (\> 1cm) or cysts crossing the head-neck junction

• Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)

• Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head

• Inflammatory arthritis such as rheumatoid arthritis (RA)

• Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable

• Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2

⁃ Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)

⁃ Severe medical comorbidities, including:

• severe cardiopulmonary disease,

∙ congestive heart failure,

∙ severe liver or kidney dysfunction,

∙ end-stage renal disease,

∙ severe uncontrolled diabetes,

∙ history of IV drug use,

∙ history of hypercoagulable state or pulmonary embolism,

∙ severe lumbar spinal stenosis,

∙ vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,

• neuropathic arthropathy (Charcot joint),

• immunosuppression or other immunodeficiency disorders, e.g., diseases such as Acquired Immune Deficiency Syndrome (AIDS) or post-organ transplant and on high doses of corticosteroids.

⁃ Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)

⁃ BMI \> 40

⁃ Active or suspected infection in or around the hip joint

⁃ Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials

⁃ Pregnant or plan to become pregnant during the study duration

⁃ Current smoker

Locations
United States
Florida
Florida Medical Clinic Orlando Health
RECRUITING
Tampa
Illinois
Rush University Medical Center
RECRUITING
Chicago
Maryland
Sinai Hospital / LifeBridge Health
RECRUITING
Baltimore
New York
NYU Longone
RECRUITING
New York
Ohio
Joint Implant Surgeons
RECRUITING
New Albany
Oregon
Oregon Health & Science University
RECRUITING
Portland
South Carolina
Midlands Orthopaedics & Neurosurgery
RECRUITING
Columbia
Virginia
Hampton Road Orthopaedics
RECRUITING
Newport News
Washington
Spokane Joint Replacement Center
RECRUITING
Spokane
Other Locations
Bermuda
Orthopaedic and Physiotherapy Associates
RECRUITING
Paget
Contact Information
Primary
Steve Meakins Vice President, Quality and Regulatory Affairs
steve@jointmedica.com
01905 640008
Backup
Sharat Kusuma, MD
Sharat@jointmedica.com
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2028-01
Participants
Target number of participants: 238
Treatments
Experimental: Polymotion Hip Resurfacing (PHR) System
The investigational device, Polymotion Hip Resurfacing System (Polymotion or PHR), is a metal-onpolyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.~Both components are designed to be permanently implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasty, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.
Sponsors
Leads: JointMedica Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.