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

NCT02301182 | Enrolling By Invitation

• 1 other identifier: VEK-44819
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasties, Hip Replacement

Outcome Measures

Primary Outcomes (3)

• Motion analysis (accelerometer (Ax3 Axivity) based activity monitoring)

  For all participants: Inertia sensors are a new technology for patient motion analysis which allows simple and fast routine clinical movement analysis and long-term activity monitoring. We will employ the newest generation of accelerometer (Ax3 Axivity) based activity monitoring (small, light, low cost, validated for orthopaedic patients also with walking aids) to count, in real life, the number of events and the duration of postures and activities. Further muscle power investigations such as by use of the legg extension power rig will be used.

  5 year

• questionnaires ("the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, satisfaction, dislocation, and revisions)

  For all participants: Pre- and postoperative clinical evaluations will be made according to "the Harris Hip Score" (HHS), the Oxford Hip Score (OHS), the HOOS score, and satisfaction, dislocations and revisions will be noted. Moreover, pre-operative rest and motion pains will be assessed by visual analogue scale scores (VAS).

  5 year

• Radiography (implant migration and wear)

  For all participants: Within a week following surgery a stereo x-ray is performed and this functions as the baseline for future follow-up (in this study at 1 year, 2 years and 5 years). When comparing all stereo x-rays in a patient series, implant migration with respect to a set of bone markers can be calculated in three dimensions as a function of time - similarly wear of the implant surfaces can be evaluated.Fluoroscopic stereoradiometric recordings (Dynamic RSA) can be used to assess the functional motion of implants at desired motion speeds. In this study we record the liner motion of the ADM cup with the patients in different positions that in theory stresses the motion of the liner into new positions at edge-motions. The purpose is to gain knowledge on the safety function of the implant in vivo - if the liner moves and if it positions safely like it is supposed to.

  5 year

Study Arms (2)

ADM X3-MoP Cup

ACTIVE COMPARATOR

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)

Device: ADM X3-MoP Cup

CoC Cup

ACTIVE COMPARATOR

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

Device: CoC Cup

Interventions

ADM X3-MoP Cup DEVICE

ADM X3-MoP Cup

CoC Cup DEVICE

CoC Cup

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34907467 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

DK (1)