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

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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Procedure: line-to-line reaming and cementing technique; Procedure: standard over-reaming with 2 broach sizes

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Kristiansund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: line-to-line reaming; 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
Active Comparator: standard over-reaming; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Kristiansund Hospital
• Investigators: Study Director: Otto Schnell Husby, md phd, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Sevaldsen K, Schnell Husby O, Lian OB, Farran KM, Schnell Husby V. Is the French Paradox cementing philosophy superior to the standard cementing? A randomized controlled radiostereometric trial and comparative analysis. Bone Joint J. 2022 Jan;104-B(1):19-26. doi: 10.1302/0301-620X.104B1.BJJ-2021-0325.R2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): June 20, 2017
• Study Completion (Actual): June 20, 2017

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: surgery; Hip Prosthesis; Radiostereometric Analysis; cements
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 4.2008.1996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No