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

NCT05120063 | Active Not Recruiting DMC

• 1 other identifier: KEK Nr. 2012-0064
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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:

1. 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. 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.

Conditions

Hip Injuries; Surgery; Prosthesis User

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

3D anatomical stem

EXPERIMENTAL

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

Device: SPS monoblock stem, Symbios; Procedure: 3D planning of THR

3D non-anatomical stem

EXPERIMENTAL

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

Device: Quadra-H, Medacta; Procedure: 3D planning of THR

2D anatomical stem

EXPERIMENTAL

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

Device: SPS monoblock stem, Symbios; Procedure: 2D planning of THR

2D non anatomical stem

EXPERIMENTAL

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

Device: Quadra-H, Medacta; Procedure: 2D planning of THR

Interventions

SPS monoblock stem, Symbios DEVICE

hip prosthesis

2D anatomical stem; 3D anatomical stem

Quadra-H, Medacta DEVICE

hip prosthesis

2D non anatomical stem; 3D non-anatomical stem

3D planning of THR PROCEDURE

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

3D anatomical stem; 3D non-anatomical stem

2D planning of THR PROCEDURE

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

2D anatomical stem; 2D non anatomical stem

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead
• Symbios Orthopedie SA: collaborator

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: November 15, 2021
• Study Start: June 1, 2012
• Primary Completion (Estimated): January 28, 2030
• Study Completion (Estimated): January 28, 2030
• Last Updated: August 15, 2023

Record last verified: 2023-08