NCT01952067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

September 5, 2013

Last Update Submit

April 28, 2022

Conditions

Osteoarthritis, Hip

Keywords

Hip ProsthesissurgerycementsRadiostereometric Analysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Oxford Hip Score

    change from 6th day postoperative to 24 months

  • EQ-5D-5L

    change from 6th day postoperative to 24 months

  • Harris Hip Score (HHS)

    change from 6th day postoperative to 24 months

  • Visual Assessment Scale (VAS) for pain

    change from 6th day postoperative to 24 months

  • Merle D'Aubigne scale

    change from 6th day postoperative to 24 months

Study Arms (2)

line-to-line reaming

EXPERIMENTAL

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

standard over-reaming

ACTIVE COMPARATOR

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

Interventions

line-to-line reaming and cementing techniquePROCEDURE
line-to-line reaming
standard over-reaming with 2 broach sizesPROCEDURE
standard over-reaming

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristiansund Hospital

Kristiansund, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34969272RESULT

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Otto Schnell Husby, md phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 27, 2013

Study Start

March 1, 2013

Primary Completion

June 20, 2017

Study Completion

June 20, 2017

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations

NO(1)