Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty
NCT ID: NCT06792539
Last Updated: 2025-10-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
238 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-01-22
Study Completion Date
2028-01-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Osteoarthritis of the Hip
Degenerative Joint Disease of Hip
Dysplasia; Hip
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
A multicenter, prospective, non-randomized, propensity score-adjusted, pivotal study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Polymotion Hip Resurfacing (PHR) System
Intervention Type
DEVICE
Surgical
Interventions
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Polymotion Hip Resurfacing (PHR) System
Surgical
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Requires primary 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.
2. Harris Hip Score \< 70 points.
3. Skeletally mature, age ≥21 and \<65 years.
4. 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:
1. Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of \>0.45.0F
2. 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
3. Osteonecrosis or avascular necrosis (AVN)
4. Multiple cysts of the femoral head (\> 1cm) or cysts crossing the head-neck junction
5. Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)
6. Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head
7. Inflammatory arthritis such as rheumatoid arthritis (RA)
8. Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
9. Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
10. Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
11. Severe medical comorbidities, including:
1. severe cardiopulmonary disease,
2. congestive heart failure,
3. severe liver or kidney dysfunction,
4. end-stage renal disease,
5. severe uncontrolled diabetes,
6. history of IV drug use,
7. history of hypercoagulable state or pulmonary embolism,
8. severe lumbar spinal stenosis,
9. vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,
10. neuropathic arthropathy (Charcot joint),
11. 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.
12. Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
13. BMI \> 40
14. Active or suspected infection in or around the hip joint
15. Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
16. Pregnant or plan to become pregnant during the study duration
17. Current smoker
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.
2. Harris Hip Score \< 70 points.
3. Skeletally mature, age ≥21 and \<65 years.
4. 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:
1. Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of \>0.45.0F
2. 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
3. Osteonecrosis or avascular necrosis (AVN)
4. Multiple cysts of the femoral head (\> 1cm) or cysts crossing the head-neck junction
5. Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)
6. Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head
7. Inflammatory arthritis such as rheumatoid arthritis (RA)
8. Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
9. Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
10. Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
11. Severe medical comorbidities, including:
1. severe cardiopulmonary disease,
2. congestive heart failure,
3. severe liver or kidney dysfunction,
4. end-stage renal disease,
5. severe uncontrolled diabetes,
6. history of IV drug use,
7. history of hypercoagulable state or pulmonary embolism,
8. severe lumbar spinal stenosis,
9. vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,
10. neuropathic arthropathy (Charcot joint),
11. 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.
12. Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
13. BMI \> 40
14. Active or suspected infection in or around the hip joint
15. Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
16. Pregnant or plan to become pregnant during the study duration
17. Current smoker
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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JointMedica Inc.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michael Mont, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Florida Medical Clinic Orlando Health
Tampa, Florida, United States
Site Status
RECRUITING
Rush University Medical Center
Chicago, Illinois, United States
Site Status
RECRUITING
Sinai Hospital / LifeBridge Health
Baltimore, Maryland, United States
Site Status
RECRUITING
NYU Longone
New York, New York, United States
Site Status
RECRUITING
Joint Implant Surgeons
New Albany, Ohio, United States
Site Status
RECRUITING
Oregon Health & Science University
Portland, Oregon, United States
Site Status
RECRUITING
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, United States
Site Status
RECRUITING
Hampton Road Orthopaedics
Newport News, Virginia, United States
Site Status
RECRUITING
Spokane Joint Replacement Center
Spokane, Washington, United States
Site Status
RECRUITING
Orthopaedic and Physiotherapy Associates
Paget, Trevelyan, Bermuda
Site Status
RECRUITING
Countries
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United States
Bermuda
Central Contacts
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Steve Meakins Vice President, Quality and Regulatory Affairs
Role: CONTACT
01905 640008
Facility Contacts
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References
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Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
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Treacy RBC, Holland JP, Daniel J, Ziaee H, McMinn DJW. Preliminary report of clinical experience with metal-on-highly-crosslinked-polyethylene hip resurfacing. Bone Joint Res. 2019 Nov 2;8(10):443-450. doi: 10.1302/2046-3758.810.BJR-2019-0060.R1. eCollection 2019 Oct.
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Cadossi M, Tedesco G, Sambri A, Mazzotti A, Giannini S. Hip Resurfacing Implants. Orthopedics. 2015 Aug;38(8):504-9. doi: 10.3928/01477447-20150804-07.
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Joshi AB, Porter ML, Trail IA, Hunt LP, Murphy JC, Hardinge K. Long-term results of Charnley low-friction arthroplasty in young patients. J Bone Joint Surg Br. 1993 Jul;75(4):616-23. doi: 10.1302/0301-620X.75B4.8331119.
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Dorr LD, Kane TJ 3rd, Conaty JP. Long-term results of cemented total hip arthroplasty in patients 45 years old or younger. A 16-year follow-up study. J Arthroplasty. 1994 Oct;9(5):453-6. doi: 10.1016/0883-5403(94)90090-6.
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Bradley GW, Freeman MA, Revell PA. Resurfacing arthroplasty. Femoral head viability. Clin Orthop Relat Res. 1987 Jul;(220):137-41.
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Hu D, Tie K, Yang X, Tan Y, Alaidaros M, Chen L. Comparison of ceramic-on-ceramic to metal-on-polyethylene bearing surfaces in total hip arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Feb 3;10:22. doi: 10.1186/s13018-015-0163-2.
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Varnum C. Outcomes of different bearings in total hip arthroplasty - implant survival, revision causes, and patient-reported outcome. Dan Med J. 2017 Mar;64(3):B5350.
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Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.
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Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJ. Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty. Clin Orthop Relat Res. 2011 Jun;469(6):1651-9. doi: 10.1007/s11999-010-1682-0.
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Visuri T, Borg H, Pulkkinen P, Paavolainen P, Pukkala E. A retrospective comparative study of mortality and causes of death among patients with metal-on-metal and metal-on-polyethylene total hip prostheses in primary osteoarthritis after a long-term follow-up. BMC Musculoskelet Disord. 2010 Apr 23;11:78. doi: 10.1186/1471-2474-11-78.
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Smith AJ, Dieppe P, Porter M, Blom AW; National Joint Registry of England and Wales. Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics. BMJ. 2012 Apr 3;344:e2383. doi: 10.1136/bmj.e2383.
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Kendal AR, Prieto-Alhambra D, Arden NK, Carr A, Judge A. Mortality rates at 10 years after metal-on-metal hip resurfacing compared with total hip replacement in England: retrospective cohort analysis of hospital episode statistics. BMJ. 2013 Nov 27;347:f6549. doi: 10.1136/bmj.f6549.
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Gill HS, Grammatopoulos G, Adshead S, Tsialogiannis E, Tsiridis E. Molecular and immune toxicity of CoCr nanoparticles in MoM hip arthroplasty. Trends Mol Med. 2012 Mar;18(3):145-55. doi: 10.1016/j.molmed.2011.12.002. Epub 2012 Jan 12.
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Catalani S, Rizzetti MC, Padovani A, Apostoli P. Neurotoxicity of cobalt. Hum Exp Toxicol. 2012 May;31(5):421-37. doi: 10.1177/0960327111414280. Epub 2011 Jul 5.
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Gessner BD, Steck T, Woelber E, Tower SS. A Systematic Review of Systemic Cobaltism After Wear or Corrosion of Chrome-Cobalt Hip Implants. J Patient Saf. 2019 Jun;15(2):97-104. doi: 10.1097/PTS.0000000000000220.
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McMinn D, Daniel J. History and modern concepts in surface replacement. Proc Inst Mech Eng H. 2006 Feb;220(2):239-51. doi: 10.1243/095441105X68944.
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Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018 Sep 5;100(17):1455-1460. doi: 10.2106/JBJS.17.01617.
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Pivec R, Johnson AJ, Mears SC, Mont MA. Hip arthroplasty. Lancet. 2012 Nov 17;380(9855):1768-77. doi: 10.1016/S0140-6736(12)60607-2. Epub 2012 Sep 26.
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Bohler C, Weimann P, Alasti F, Smolen JS, Windhager R, Aletaha D. Rheumatoid arthritis disease activity and the risk of aseptic arthroplasty loosening. Semin Arthritis Rheum. 2020 Apr;50(2):245-251. doi: 10.1016/j.semarthrit.2019.07.011. Epub 2019 Aug 1.
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Swarup I, Sutherland R, Burket JC, Figgie MP. Total hip arthroplasty in young patients with post-traumatic arthritis of the hip. Hip Int. 2017 Nov 21;27(6):546-550. doi: 10.5301/hipint.5000499. Epub 2017 May 23.
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Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
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Related Links
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Other Identifiers
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CI001
Identifier Type: -
Identifier Source: org_study_id
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