Clinical trial NCT01952067: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Hip Prosthesis
surgery
cements
Radiostereometric Analysis
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Kristiansund Hospital
name: St. Olavs Hospital
First posted: 2013-09-27
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Difference in subsidence of femoral stems of 200 microns
timeFrame: change from 6th day postoperative to 24 months
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: change from 6th day postoperative to 24 months
measure: EQ-5D-5L
timeFrame: change from 6th day postoperative to 24 months
measure: Harris Hip Score (HHS)
timeFrame: change from 6th day postoperative to 24 months
measure: Visual Assessment Scale (VAS) for pain
timeFrame: change from 6th day postoperative to 24 months
measure: Merle D'Aubigne scale
timeFrame: change from 6th day postoperative to 24 months
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Otto Schnell Husby, md phd
role: STUDY_DIRECTOR
References:
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.