Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients

NCT ID: NCT02301182

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2027-11-30

Brief Summary

A Single-Center Randomized, Patient-Blinded, Prospective Five-Year Study to Compare the Functional Results after Insertion of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Primary THA. 60 patients will be enrolled during a 2 year period. At surgery tantalum beads will be inserted into predrilled holes of the polyethylene rim for assessment of motion of the large mobile poly in the ADM Trident Cup by use of RSA. Patients will be followed by functional examinations as well as PROM assessment.

Detailed Description

With Metal-on-Metal (MoM) articulations leaving the marked the THA bearing choice for younger patients is currently debated and overall the choice stands between CoC and MoP. New HXLPE is wear-resistant and safe and clinical HXLPE wear (RSA) hardly exceed the wear measured in retrieval CoC implants. For CoC articulations stripe wear on edge loading is a reported problem leading to increased wear in examined retrieval components and CoC wear is dependent on component position. Although the risk is very small, CoC bearings are at still at risk of fracture, and functional squeaking is a complication that adversely affects the quality of life in about 1% of CoC THA patient. Dual mobility MoP cups were designed for reducing hip dislocations in older patients treated with THA after medial hip fractures. The concept provides good stability and mobility and may also be an optimal solution for younger and active patients; however, dual mobility MoP has not previously been documented for use in younger patients. The anatomical dual mobility (ADM) cup design (Stryker) is soft tissue sparing (iliopsoas tendon) potentially leading to lesser groin-pain and squeaking is not a concern. It is currently unknown if the outer-articulation of the dual mobility PE liner keeps moving over time or could impinge in the joint capsule in an undesirable position and result in unwanted edge loading and higher wear-rates. Metal ions are produced even in MoP bearings and even though in dual-articulation MoP bearings most (90%) of the motion is believed to occur between the head and liner (ceramic-polyenthylene), the metal ion levels may be higher than expected for MoP hips (large poly contact in metal shell), while expectedly there will be no metal ions in CoC THA.

Conditions

Arthroplasties, Hip Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ADM X3-MoP Cup

THA: ADM dual-mobility hydroxyapatite coated cups with X3TM HXLPE liners on 28mm BIOLOX® delta femoral heads (Stryker) with femoral stems being 2nd generation Accolade stems of the taper lock type, proximal circumferential coated with a 50µm plasma-spray PureFix HA coating to aid the mechanical engagement in bone coating (Stryker)

Group Type: ACTIVE_COMPARATOR

ADM X3-MoP Cup

Intervention Type: DEVICE

CoC Cup

THA: CoC BIOLOX® delta-delta large-head single-mobility cementless fiber-mesh titanium coated acetabular system from Zimmer (Zimmer TrilogyIT cup/CLS spotorno stem) with a grit-blasted osteophilic titanium alloy CLS® Spotorno femoral stems (Zimmer) that has a three-dimensional wedge shape and sharpened ribs in the proximal region

Group Type: ACTIVE_COMPARATOR

CoC Cup

Intervention Type: DEVICE

Interventions

ADM X3-MoP Cup

Intervention Type: DEVICE

CoC Cup

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• primary hip osteoarthritis
• sufficient bone quality for total hip arthroplasty
• age 40 through 65 years of age
• informed and written consent
• patient can only enter the project with one hip

Exclusion Criteria

• neuromuscular or vascular disease in the affected leg
• patients with osteoporosis
• fracture sequelae or previous extensive hip surgery
• patients with metabolic bone disease including rheumatoid arthritis
• non-Danish citizenship
• patients who do not comprehend the Danish language
• senile dementia
• alcoholism and drug abuse
• major psychiatric disease
• current metastatic cancer disease and on-going treatment with radiation therapy/chemotherapy
• severe systemic disease affecting gait
• contralateral knee, hip and/or spine disease
• on-going case regarding industrial injury insurance of the hip
• patients with very poor dental status

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

References

Jorgensen PB, Kaptein BL, Soballe K, Jakobsen SS, Stilling M. Combined and hybrid marker models for radiostereometry assessment of polyethylene liner motion in dual mobility hip prosthesis: a proof-of-concept study. Eur Radiol Exp. 2021 Dec 15;5(1):55. doi: 10.1186/s41747-021-00253-x.

Reference Type: DERIVED

PMID: 34907467 (View on PubMed)

Other Identifiers

VEK-44819

Identifier Type: -

Identifier Source: org_study_id