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

N

Norwegian University of Science and Technology

Status

Completed

Conditions

Osteoarthritis, Hip

Treatments

Procedure: standard over-reaming with 2 broach sizes
Procedure: line-to-line reaming and cementing technique

Study type

Interventional

Funder types

Other

Identifiers

NCT01952067
4.2008.1996

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

55 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

line-to-line reaming
Experimental group
Description:
Corail cemented femoral stem using line-to-line reaming and cementing technique, 28mm Alumine Biolox forte femoral head, Marathon cup
Treatment:
Procedure: line-to-line reaming and cementing technique
standard over-reaming
Active Comparator group
Description:
Corail cemented femoral stem using standard over-reaming with 2 broach sizes, 28mm Alumine Biolox forte femoral head, Marathon cup
Treatment:
Procedure: standard over-reaming with 2 broach sizes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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