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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Hip Injuries; Prosthesis User
• Intervention / Treatment: Device: SPS monoblock stem, Symbios; Procedure: 3D planning of THR; Device: Quadra-H, Medacta; Procedure: 2D planning of THR

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D anatomical stem; 3-D-Planing with anatomical stem (SPS monoblock stem, Symbios)	Device: SPS monoblock stem, Symbios; hip prosthesis; Procedure: 3D planning of THR; primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)
Experimental: 3D non-anatomical stem; 3-D-Planing with non anatomical stem (Quadra-H, Medacta)	Procedure: 3D planning of THR; primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography); Device: Quadra-H, Medacta; hip prosthesis
Experimental: 2D anatomical stem; 2-D-Planing with anatomical stem (SPS monoblock stem, Symbios)	Device: SPS monoblock stem, Symbios; hip prosthesis; Procedure: 2D planning of THR; primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)
Experimental: 2D non anatomical stem; 2-D-Planning with non anatomical Stem (Quadra-H, Medacta)	Device: Quadra-H, Medacta; hip prosthesis; Procedure: 2D planning of THR; primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from basline to one year
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%.	Change from basline to one year

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Collaborators: Symbios Orthopedie SA

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Estimated): January 28, 2030
• Study Completion (Estimated): January 28, 2030

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries
• Other Study ID Numbers: KEK Nr. 2012-0064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No