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

N/ACompletedNCT01952067

Norwegian University of Science and Technology48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Hip

Interventions

line-to-line reaming and cementing techniquePROCEDURE

standard over-reaming with 2 broach sizesPROCEDURE

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kristiansund Hospital

Kristiansund, Norway

Outcomes

Primary Outcomes

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

Time frame: change from 6th day postoperative to 24 months

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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