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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05120063
• Other study ID #: KEK Nr. 2012-0064
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: January 28, 2030

Study information

• Verified date: August 2023
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: January 28, 2030
• Est. primary completion date: January 28, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries
• Prosthesis User
• Surgery

Intervention

Device:
• SPS monoblock stem, Symbios
hip prosthesis
• Quadra-H, Medacta
hip prosthesis

Procedure:
• 3D planning of THR
primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)
• 2D planning of THR
primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	Symbios Orthopedie SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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