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

NCT03409666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-14

Study results available
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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.

Conditions

  • Hip Osteoarthritis
  • Noninflammatory Degenerative Joint Disease
  • Avascular Necrosis
  • Correction of Functional Deformity
  • Rheumatoid Arthritis

Interventions

DEVICE

Taperloc Complete Microplasty stem

Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner

DEVICE

Taperloc Complete Reduced Distal stem

Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Paola Vivoda, BSc · Zimmer Biomet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409666 on ClinicalTrials.gov