Taperloc Versus Taplerloc Microplasty

Ingemar Ivarsson

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Taperloc Microplasty

Device: Taperloc standard

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00757107

GBMET.CR.ROWEU1

Details and patient eligibility

About

This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Full description

Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Enrollment

60 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Patients with primary osteoarthritis of the hip scheduled for THA.
Suitable anatomy for both stems
Willingness and ability to follow study-protocol

Exclusion Criteria

Malignancy or metastatic bone disease.
Any other disease severely affecting bone and mineral metabolism
Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.