SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-10-31

Brief Summary

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A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

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Detailed Description

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The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.

Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Bone cement 1

Intervention Type DEVICE

Bone cement SmartSet® HV

2

Group Type ACTIVE_COMPARATOR

Bone cement 2

Intervention Type DEVICE

Bone cement Palacos R

Interventions

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Bone cement 1

Bone cement SmartSet® HV

Intervention Type DEVICE

Bone cement 2

Bone cement Palacos R

Intervention Type DEVICE

Other Intervention Names

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SmartSet HV Palacos R

Eligibility Criteria

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Inclusion Criteria

* patients in need for total hip arthroplasty

Exclusion Criteria

* patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
* patients on corticosteroid treatment,
* patients who had already participated in a clinical study with an investigational product in the last 6 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No