search
Back to results

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

Primary Purpose

Hip Injuries, Surgery, Prosthesis User

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPS monoblock stem, Symbios
Quadra-H, Medacta
3D planning of THR
2D planning of THR
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hip Injuries

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    3D anatomical stem

    3D non-anatomical stem

    2D anatomical stem

    2D non anatomical stem

    Arm Description

    3-D-Planing with anatomical stem (SPS monoblock stem, Symbios)

    3-D-Planing with non anatomical stem (Quadra-H, Medacta)

    2-D-Planing with anatomical stem (SPS monoblock stem, Symbios)

    2-D-Planning with non anatomical Stem (Quadra-H, Medacta)

    Outcomes

    Primary Outcome Measures

    Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    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.
    Change in subjective hip value (SHV)
    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%.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2021
    Last Updated
    August 14, 2023
    Sponsor
    Balgrist University Hospital
    Collaborators
    Symbios Orthopedie SA
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05120063
    Brief Title
    Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study
    Official Title
    Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    June 1, 2012 (Actual)
    Primary Completion Date
    January 28, 2030 (Anticipated)
    Study Completion Date
    January 28, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Balgrist University Hospital
    Collaborators
    Symbios Orthopedie SA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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: 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. 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Injuries, Surgery, Prosthesis User

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    133 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3D anatomical stem
    Arm Type
    Experimental
    Arm Description
    3-D-Planing with anatomical stem (SPS monoblock stem, Symbios)
    Arm Title
    3D non-anatomical stem
    Arm Type
    Experimental
    Arm Description
    3-D-Planing with non anatomical stem (Quadra-H, Medacta)
    Arm Title
    2D anatomical stem
    Arm Type
    Experimental
    Arm Description
    2-D-Planing with anatomical stem (SPS monoblock stem, Symbios)
    Arm Title
    2D non anatomical stem
    Arm Type
    Experimental
    Arm Description
    2-D-Planning with non anatomical Stem (Quadra-H, Medacta)
    Intervention Type
    Device
    Intervention Name(s)
    SPS monoblock stem, Symbios
    Intervention Description
    hip prosthesis
    Intervention Type
    Device
    Intervention Name(s)
    Quadra-H, Medacta
    Intervention Description
    hip prosthesis
    Intervention Type
    Procedure
    Intervention Name(s)
    3D planning of THR
    Intervention Description
    primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)
    Intervention Type
    Procedure
    Intervention Name(s)
    2D planning of THR
    Intervention Description
    primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)
    Primary Outcome Measure Information:
    Title
    Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Description
    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.
    Time Frame
    Change from basline to one year
    Title
    Change in subjective hip value (SHV)
    Description
    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%.
    Time Frame
    Change from basline to one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs