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Active, Not Recruiting

NCT Number: NCT05120063

Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study

In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.

Hypothesis:

1. When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants. 2. When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hip Injuries Prosthesis User Surgery Wounds and Injuries

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients sent to our outpatient clinic for eventual primary THR are informed about this study and written patient information given to them. When patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included.

Block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms.

Patients will be blinded for the type of stem and method of planning. Investigators are blined in terms of methods of planning. In terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it.

The preoperative investigation includes routine investigation and an additional CT scan plus evaluation of the "University of California at Los Angeles" (UCLA) activity level and "Short Form Health 36" (SF-36) score. The same applies for the postoperative investigation and 3 months. The follow-up visits at 1, 5 and 10 years are routine investigations with additional UCLA and SF-36 Scores.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 40-70 years scheduled for primary THR
  • signed written informed consent.

Exclusion criteria

  • Charnley class B and C
  • ASA score >2
  • pregnancy
  • gross hip deformity making complex hip reconstruction (greater trochanter advancement, acetabular augmentation, femoral osteotomy, use of cemented or revision stem) necessary
  • immature patients and patients incompetent to judge

Treatment and study plan

SPS monoblock stem, Symbios

Device

hip prosthesis

Quadra-H, Medacta

Device

hip prosthesis

3D planning of THR

Procedure

primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)

2D planning of THR

Procedure

primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)

Primary outcomes

  1. Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Change from basline to one year

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients, including pain, stiffness, and physical functioning of the hip.

    A difference in WOMAC of 2.5 points is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year WOMAC significantly differs by 2.5.

  2. Change in subjective hip value (SHV)

    Time frame: Change from basline to one year

    The subjective hip value (SHV) is as a patient-reported outcome measurement (PROM) which is reported by the patient. It is easily and quickly performed and interpreted. The SHV is defined as a patient's subjective hip satisfaction expressed as a percentage of 100%, which is the score that an entirely normal hip joint would reach.

    A difference in subj. hip value of 25% is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year subjective hip value significantly differs by 25%.

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • Symbios Orthopedie SA

Registry information

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Nov 15, 2021
Registry last updated
Aug 15, 2023

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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