Application of 3D-printed osteotomy guide in total hip arthroplasty via direct anterior approach

Application of 3D-printed osteotomy guide-assisted femoral osteotomy in total hip arthroplasty via direct anterior approach

Registry ID
ISRCTN15185020
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Luoyang Orthopedic-Traumatological Hospital of Henan Province
Enrollment
110
Start date
2026-07-01
Completion date
2028-06-30
Last update
2026-08-17

Conditions

Summary

Total hip arthroplasty in patients with osteonecrosis of the femoral head

Detailed description

Patients were randomly assigned to either the research group or the control group using a computer-generated randomization sequence to ensure unbiased allocation. The detailed surgical interventions for the two groups are described as follows: - Experimental Group (DAA approach combined with 3D-printed osteotomy guide plate) CT scans of the patient’s bilateral hips are performed to obtain DICOM data. Mimics 19 software is used for image processing and three-dimensional reconstruction of the proximal femur. Based on the anterior anatomical contour of the femoral head and neck, the osteotomy plane is determined at 1.0 cm above the lesser trochanter, and an osteotomy guide plate with 1.5 mm Kirschner wire fixation holes is designed. The femoral model and the customized osteotomy guide plate model are manufactured via 3D printing. In vitro preoperative simulated surgery is conducted to evaluate the accuracy and strength of the guide plate. After necessary modifications, the guide plate is sterilized by low-temperature plasma for application. Surgical procedure: A standard direct anterior approach (DAA) is adopted to establish the surgical access and perform acetabular management. For the femoral side, sufficient release and exposure of the intertrochanteric line of the femoral head and neck are performed. The customized 3D-printed osteotomy guide plate is fully fitted to the osteotomy area of the proximal femur and temporarily fixed with Kirschner wires. The oscillating saw is guided through the groove of the guide plate to perform a precise femoral neck osteotomy. Subsequently, standard procedures including proximal femoral medullary cavity opening and reaming are completed, followed by implantation of appropriately sized femoral stem and femoral head prostheses. - Control Group (simple DAA approach) All surgical operations are completed via a standard DAA approach. The acetabular management procedure is identical to that in the experimental group. For femoral neck

Interventions

Inclusion criteria

1. The diagnostic criteria for osteonecrosis of the femoral head (ARCO stage IIIB-IV) or hip osteoarthritis, requiring primary unilateral total hip arthroplasty 2. No severe functional impairment of vital organs such as the heart, lungs, liver or kidneys, and able to tolerate surgery 3. Normal mental status and good cognitive function, able to cooperate with follow-up and related examinations 4. Voluntarily participate in the study and able to cooperate with follow-up

Exclusion criteria

1. Presence of active infection in the joint or other body sites 2. Concomitant inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis 3. Concomitant other severe joint diseases, bone tumors, or severe osteoporosis 4. Previous surgical history of the ipsilateral hip joint 5. Lower limb muscle strength or mobility impairment caused by neurological diseases

Locations

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