Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-06-20

Brief Summary

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The primary aim of the study is to compare migration of the cemented Corail stem representing polished surfaced versions of the femoral stem. Two different methods will be used for reaming the femoral canal and cementing of the stem. Radiostereometric analysis (RSA) will be used in migration measurements.

Furthermore pain, postoperative outcome and patient satisfaction will be assessed.

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Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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line-to-line reaming

Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup

Group Type EXPERIMENTAL

line-to-line reaming and cementing technique

Intervention Type PROCEDURE

standard over-reaming

Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup

Group Type ACTIVE_COMPARATOR

standard over-reaming with 2 broach sizes

Intervention Type PROCEDURE

Interventions

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line-to-line reaming and cementing technique

Intervention Type PROCEDURE

standard over-reaming with 2 broach sizes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring cemented primary total hip replacement.
* Patients with a diagnosis of osteoarthritis, avascular necrosis or post-traumatic arthritis
* Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery

Exclusion Criteria

* Patients who require revision of a previously implanted total hip replacement (THR)
* Patients who will receive a THR without cement
* Patients who have had a prior procedure of osteotomy on the femur
* Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI \>35)
* Patients with active or suspected infection
* Patients with malignancy

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No