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

NCT ID: NCT03409666

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2020-11-06

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Taperloc Complete Microplasty stem

Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.

Group Type: EXPERIMENTAL

Taperloc Complete Microplasty stem

Intervention Type: DEVICE

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

Taperloc Complete Reduced Distal stem

Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.

Group Type: ACTIVE_COMPARATOR

Taperloc Complete Reduced Distal stem

Intervention Type: DEVICE

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

Interventions

Taperloc Complete Microplasty stem

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

Intervention Type: DEVICE

Taperloc Complete Reduced Distal stem

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

Intervention Type: DEVICE

Other Intervention Names

Total hip arthroplasty; Total hip arthroplasty

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Vivoda, BSc

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Bravis

Roosendaal, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ORTHO.CR.GH60

Identifier Type: -

Identifier Source: org_study_id