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Efficacy and safety of the navigation system for total hip arthroplasty: A prospective, multicenter, randomized, open-label, parallel-group trial

Efficacy and safety of the navigation system for total hip arthroplasty: A prospective, multicenter, randomized, open-label, parallel-group trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080365
Enrollment
Unknown
Registered
2024-01-26
Start date
2022-07-01
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Bone diseases

Interventions

Experimental group:Navigation system assisted total hip arthroplasty
Control group:Routine Surgical Procedures

Sponsors

The Fourth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 80 years old (including 18 and 80 years old), regardless of gender; 2. Patients should have indications for hip replacement surgery; 3. Patients are willing to participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with neuromuscular insufficiency (e.g., paralysis, myolysis, or abductor weakness) that would result in postoperative hip instability or abnormal gait; 2. Active infection of the hip or other body parts; 3. Patients with severe hip deformity or CROWE grade 3 or 4 developmental dysplasia of the hip; 4. Patients with ankylosing spondylitis with bony ankylosis or severe stiffness; 5. Patients undergoing bilateral hip arthroplasty at the same time, or patients with contralateral hip arthroplasty within 3 months, or patients with contralateral hip arthroplasty expected within 1 year after surgery; 6. The patient is known to be allergic to one or more implant materials; 7. Patients with severe medical or surgical diseases or weak constitution who cannot tolerate surgery; 8. Patients with predicted poor compliance; 9. Pregnant or lactating women or patients who plan to have a child during the trial; 10. Patients were enrolled or were enrolled in a drug clinical trial within 3 months before enrollment or in a clinical trial of another device within 1 month before enrollment; 11. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Plan accuracy in component size;Cup inclination/anteversion;

Secondary

MeasureTime frame
Percentage of acetabular cup position in safe zone;Leg length discrepancy;Operation time;Functional outcome;Blood Loss;Inflammation indicators;Complications;

Countries

China

Contacts

Public ContactWeiChai

The Fourth Medical Center of Chinese PLA General Hospital

pchen@changmugu.com+86 135 1103 3835

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026