Skip to main content
OpenTrials
Completed

NCT Number: NCT01010763

A Study on M2a Magnum Total Hip Arthroplasty

The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Joint Disease Avascular Necrosis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansai Rosai Hospital

Amagasaki, Hyogo Pref., 660-8511, Japan

About this study

There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suitable for primary Total Hip Replacement
  • Patients aged over 20
  • Patients with limited co-morbidity- ASA I-III
  • Patients must be able to understand instructions and be willing to return for follow-up
  • Patients willing to provide blood and urine samples for metal ion analysis at follow-up

Exclusion criteria

  • Pre-existing metal implants
  • Infection, sepsis, and osteomyelitis
  • Uncooperative patient or pt with neurologic disorders who are incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • osteomalacia
  • distant foci of infections which may spread to the implant site
  • rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • vascular insufficiency, muscular atrophy, or neuromuscular disease
  • pregnancy

Treatment and study plan

Total hip arthroplasty

Device

Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

Primary outcomes

  1. Range of Motion

    Time frame: 1 year

    Hip Flexion Angle at 1 year postoperatively

Secondary outcomes

  1. Metal Ion

    Time frame: 3 month

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  2. UCLA Activity Score

    Time frame: 5 year

    UCLA is physician assessing scoring system to assess patient's activity level. Minimum score is 0 (completely inactive) and maximum score is 9 (Regularly participates in impact sports) with 1 point increments depending on patient's activity level.

    Higher score means higher activity level achieved.

  3. Radiographic Assessment

    Time frame: 5 year

    number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)

  4. Harris Hip Score

    Time frame: 5 year

    Harris Hip Score is physician assessing hip functional scoring system, which includes 4 components (pain, function, deformity and range of motion) with minimum score of 0 & maximum score of 100.

    Maximum & Minimum score of each subscale is pain: 0-44, function: 0-47, Deformity: 0-4 and Range of motion: 0-5.

    Current report uses summed score of each patient to compare total Harris Hip Score.

    Higher score means better outcomes.

  5. Metal Ion

    Time frame: 6 month

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  6. Metal Ion

    Time frame: 1 year

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  7. Metal Ion

    Time frame: 2 year

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  8. Metal Ion

    Time frame: 3 year

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  9. Metal Ion

    Time frame: 4 year

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

  10. Metal Ion

    Time frame: 5 year

    Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Nov 10, 2009
Registry last updated
Jun 21, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.