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

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
line-to-line reaming and cementing technique
standard over-reaming with 2 broach sizes
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Hip Prosthesis, surgery, cements, Radiostereometric Analysis

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kristiansund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

line-to-line reaming

standard over-reaming

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
September 5, 2013
Last Updated
April 28, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
Kristiansund Hospital, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01952067
Brief Title
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis
Official Title
Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis. A Randomized Single-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Kristiansund Hospital, St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Hip Prosthesis, surgery, cements, Radiostereometric Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
line-to-line reaming
Arm Type
Experimental
Arm Description
Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup
Arm Title
standard over-reaming
Arm Type
Active Comparator
Arm Description
Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup
Intervention Type
Procedure
Intervention Name(s)
line-to-line reaming and cementing technique
Intervention Type
Procedure
Intervention Name(s)
standard over-reaming with 2 broach sizes
Primary Outcome Measure Information:
Title
Difference in subsidence of femoral stems of 200 microns
Description
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 Outcome Measure Information:
Title
Oxford Hip Score
Description
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
Title
EQ-5D-5L
Description
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
Title
Harris Hip Score (HHS)
Description
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.
Time Frame
change from 6th day postoperative to 24 months
Title
Visual Assessment Scale (VAS) for pain
Description
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.
Time Frame
change from 6th day postoperative to 24 months
Title
Merle D'Aubigne scale
Description
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.
Time Frame
change from 6th day postoperative to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto Schnell Husby, md phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Kristiansund Hospital
City
Kristiansund
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34969272
Citation
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.
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Comparison of Two Cementing Techniques of the Femoral Component in a Hip Prosthesis

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