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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952067
• Other study ID #: 4.2008.1996
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 20, 2017

Study information

• Verified date: April 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• line-to-line reaming and cementing technique

• standard over-reaming with 2 broach sizes

Locations

Country	Name	City	State
Norway	Kristiansund Hospital	Kristiansund

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Kristiansund Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Sevaldsen K, Schnell Husby O, Lian ØB, 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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