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

NCT ID: NCT05120063

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2030-01-28

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. 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.

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.

Conditions

Hip Injuries; Surgery; Prosthesis User

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

2D anatomical stem

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

Group Type: EXPERIMENTAL

SPS monoblock stem, Symbios

Intervention Type: DEVICE

hip prosthesis

2D planning of THR

Intervention Type: PROCEDURE

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

2D non anatomical stem

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

Group Type: EXPERIMENTAL

Quadra-H, Medacta

Intervention Type: DEVICE

hip prosthesis

2D planning of THR

Intervention Type: PROCEDURE

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

3D anatomical stem

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

Group Type: EXPERIMENTAL

SPS monoblock stem, Symbios

Intervention Type: DEVICE

hip prosthesis

3D planning of THR

Intervention Type: PROCEDURE

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

3D non-anatomical stem

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

Group Type: EXPERIMENTAL

Quadra-H, Medacta

Intervention Type: DEVICE

hip prosthesis

3D planning of THR

Intervention Type: PROCEDURE

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

Interventions

SPS monoblock stem, Symbios

hip prosthesis

Intervention Type: DEVICE

Quadra-H, Medacta

hip prosthesis

Intervention Type: DEVICE

3D planning of THR

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

Intervention Type: PROCEDURE

2D planning of THR

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symbios Orthopedie SA

INDUSTRY

Sponsor Role: collaborator

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KEK Nr. 2012-0064

Identifier Type: -

Identifier Source: org_study_id