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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15185020
Enrollment
110
Registered
2026-06-15
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total hip arthroplasty in patients with osteonecrosis of the femoral head Surgery

Interventions

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 f

Sponsors

Luoyang Orthopedic-Traumatological Hospital of Henan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Consistency of femoral osteotomy height, defined as the absolute difference between the actual osteotomy level, measured using postoperative computed tomography (CT) at postoperative day 3 (POD 3)

Secondary

MeasureTime frame
Leg length discrepancy (LLD) measured using digital radiography (DR) at postoperative day 3 (POD 3);Pain measured using a Visual Analog Scale (VAS) pain score at postoperative day 1 (POD 1) and 3 (POD 3);Assessment of the results of total hip arthroplasty (THA) measured using the Harris Hip Score (HHS) at Postoperative day 7 (POD 7) and postoperative 3 months

Countries

China

Contacts

Public ContactYanfeng Tang
tyflyzg@126.com+86 18939008728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026