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Enrolling by Invitation

NCT Number: NCT02301182

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

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.

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Key information

Conditions

Arthroplasties, Hip Replacement

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADM X3-MoP Cup

Device

CoC Cup

Device

Primary outcomes

  1. Motion analysis (accelerometer (Ax3 Axivity) based activity monitoring)

    Time frame: 5 year

    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.

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

    Time frame: 5 year

    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).

  3. Radiography (implant migration and wear)

    Time frame: 5 year

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2014
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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