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
About this trial
This is an interventional basic science trial for Hip Injuries
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
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
NCT ID
NCT05120063
First Posted
May 6, 2021
Last Updated
August 14, 2023
Sponsor
Balgrist University Hospital
Collaborators
Symbios Orthopedie SA
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
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