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NCT Number: NCT01952067

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

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kristiansund Hospital

Kristiansund, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

line-to-line reaming and cementing technique

Procedure

standard over-reaming with 2 broach sizes

Procedure

Primary outcomes

  1. Difference in subsidence of femoral stems of 200 microns

    Time frame: change from 6th day postoperative to 24 months

    Radiostereometric analysis (RSA) of implant migration: difference in translation and rotation (x-, y-, and z- axis) of the femoral stem

Secondary outcomes

  1. Oxford Hip Score

    Time frame: change from 6th day postoperative to 24 months

    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).

  2. EQ-5D-5L

    Time frame: change from 6th day postoperative to 24 months

    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.

  3. Harris Hip Score (HHS)

    Time frame: change from 6th day postoperative to 24 months

    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.

  4. Visual Assessment Scale (VAS) for pain

    Time frame: change from 6th day postoperative to 24 months

    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.

  5. Merle D'Aubigne scale

    Time frame: change from 6th day postoperative to 24 months

    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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Kristiansund Hospital
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 27, 2013
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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