NCT06792539

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: JointMedica Inc. · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The PHR® System is a single-use device consisting of a Cobalt Chromium, bone-cemented femoral head component, and a cementless acetabular component comprising of a Vitamin E polyethylene (Vit E-XPE) bearing with a titanium coating. The PHR® System is intended for patients who, due to their relatively younger age (under 65) and increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. Hip Resurfacing Arthroplasty (HRA) is a surgery that has been developed as an alternative to Total Hip Arthroplasty (THA), especially for younger, more active patients. Studies done on past designs of HRA demonstrate the following noteworthy benefits of the HRA procedure when compared with THA: bone conservation, improved gait, higher activity levels, lower rates of dislocations, reduced thigh pain, and reduced alteration in leg length. Hip resurfacing restores the natural shape of the joint meaning better stability, longevity, and higher levels of activity than a traditional hip replacement. In Total Hip Replacement, the femoral head and neck (ball joint of the hip) is removed and replaced by a long, stemmed device. The procedure is highly successful; however, in some cases the replacement hip joint has the potential to wear out much more quickly in younger, more active patients, leading to revision surgery being required. With the PHR® procedure, your surgeon removes less bone from the femoral head of the femur and retains the femoral neck. The femoral head is shaped to accept a low-wear metal cap. This spherical cap closely matches your anatomy, reducing the risk of dislocation, and offering a broad range of movement and excellent stability. The acetabular socket (cup joint of the hip) is then fitted with a corresponding polyethylene component, significantly reducing potential reactions to metal ions associated with historic Metal-on-Metal hip resurfacing devices. A comprehensive range of sizes is offered to address the needs of most patients. Both components are designed to be 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 arthroplasties, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Polymotion Hip Resurfacing (PHR) System	Surgical

Timeline

• Start date: 2025-01-22
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-01-24
• Last updated: 2025-10-30

Locations

10 sites across 2 countries: United States, Bermuda

Regulatory

• FDA-regulated device study