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

Zimmer Biomet

Status: Completed

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

Treatments: Device: Taperloc Complete Microplasty stem; Device: Taperloc Complete Reduced Distal stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT03409666

ORTHO.CR.GH60

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Taperloc Complete Microplasty stem

Experimental group

Description:

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

Treatment:

Device: Taperloc Complete Microplasty stem

Taperloc Complete Reduced Distal stem

Active Comparator group

Description:

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

Treatment:

Device: Taperloc Complete Reduced Distal stem