Thinking of joining a study?

Register your interest

Become a volunteer?

NCT03409666 | COMPLETED | Hip Osteoarthritis

Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Sponsor:

Zimmer Biomet

Brief Summary:

This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.

Condition or disease

Hip Osteoarthritis

Noninflammatory Degenerative Joint Disease

Avascular Necrosis

Correction of Functional Deformity

Rheumatoid Arthritis

Intervention/treatment

Taperloc Complete Microplasty stem

Taperloc Complete Reduced Distal stem

Phase

NA

Detailed Description:

A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner. All potential study subjects will be required to participate in the Informed Consent process.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Actual Study Start Date : 2017-05-12
Estimated Primary Completion Date : 2020-11-06
Estimated Study Completion Date : 2020-11-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
  • * Correction of functional deformity.
  • * Male or female
  • -≥ 18 and ≤ 70 years of age
  • * Subjects willing to return for follow-up evaluations.
  • * Subjects able to read and understand Dutch language.
Exclusion Criteria
  • * active Infection (or within 6 weeks after infection)
  • * Sepsis
  • * Osteomyelitis
  • * Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • * diagnosed Osteoporosis or Osteomalacia
  • * Metabolic disorders which may impair bone formation
  • * 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.
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Location Details

NCT03409666

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Netherlands,

Bravis

Roosendaal, Netherlands,