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

Study Overview
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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.

Official Title
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Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: line-to-line reaming and cementing technique
* Procedure: standard over-reaming with 2 broach sizes


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: line-to-line reaming<br>Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup | Procedure: line-to-line reaming and cementing technique<br> <br> |
| Active Comparator: standard over-reaming<br>Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup | Procedure: standard over-reaming with 2 broach sizes<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in subsidence of femoral stems of 200 microns | Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem | change from 6th day postoperative to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | 12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0). | change from 6th day postoperative to 24 months | 
| EQ-5D-5L | 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office. 5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be' 12233' We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office. | change from 6th day postoperative to 24 months | 
| Harris Hip Score (HHS) | Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | change from 6th day postoperative to 24 months | 
| Visual Assessment Scale (VAS) for pain | A horizontal or vertical 10 cm line labelled at each end by descriptors such as 'no pain' and 'worse pain ever'. The patient marks the line to indicate pain severity and it is simply quantified by measuring the distance in cm from 0 (no pain) to the patient's marked rating. | change from 6th day postoperative to 24 months | 
| Merle D'Aubigne scale | The score includes the parameters pain, mobility, and ability to walk, with each rated from 0 points (worst condition) to 6 points (best condition). Addition of the scores for pain and mobility results in an absolute estimation of hip function. | change from 6th day postoperative to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Prosthesis, surgery, cements, Radiostereometric Analysis