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Prospective, randomized, cohort study to evaluate the value of robotic technology as an adjoint in conventional posterior and direct anterior total hip arthroplasty

Prospective, multicenter, randomized, open, parallel-controlled clinical trial to evaluate the efficacy and safety of orthopedic surgical navigation and positioning system for assisted hip replacement/SSFZXT-GSYH-02

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065601
Enrollment
Unknown
Registered
2022-11-09
Start date
2022-05-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

End-stage hip disease

Interventions

experimental group 1:Robot-assisted total hip arthroplasty with direct anterior approach
experimental group 2:Total hip arthroplasty was performed through a machine-assisted posterolateral approach
control group 1:Total hip arthroplasty was performed through a posterolateral approach
control group 2:Total hip arthroplasty was performed through a direct anterior approach

Sponsors

Department of Orthopedics, the Second Affiliated Xinqiao Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years (including 18 and 80 years), both sexes; 2. The patient should have indications for hip replacement surgery; 3. Patients voluntarily participate in clinical trials and are willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with neuromuscular insufficiency (e.g., paralysis, myolysis, or abductor weakness) resulting in hip instability or gait abnormalities after surgery; 2. Active infectious lesions in the hip joint or other parts of the body; 3. Patients with severe hip deformity and hip dysplasia of CROWE grade 3 or 4; 4. Ankylosing spondylitis patients with bony ankylosis or severe rigidity; 5. Patients who underwent a simultaneous bilateral hip replacement, or who had undergone hip replacement on the contralateral side within 3 months, or who were expected to undergo hip replacement on the contralateral side within 1 year after surgery; 6. The patient is known to have a history of allergy to one or more implanted materials; 7. Patients with severe internal or surgical diseases or weak constitution, unable to tolerate surgery; 8. Patients with poor expected compliance; 9. Pregnant or lactating women, or patients with family planning during the study; 10. Patients participated in clinical trials of other drugs within 3 months before enrollment, or clinical trials of other devices within 1 month before enrollment; 11. Other circumstances deemed inappropriate by the investigator for study participation.

Design outcomes

Primary

MeasureTime frame
Accuracy of acetabular cup implantation;

Secondary

MeasureTime frame
The number of anteversion and abduction angles of acetabular cup implantation;Percentage of acetabular cups accurately implanted in the safe zone;Preoperative prosthesis specification planning accuracy and complete accuracy;Accuracy of lower limb length;Eccentricity of hip;Horizontal and vertical distance of the center of rotation (COR) of the hip joint;Harris Hip Joint Function Scale;WOMAC score;time of operation;Total and theoretical total blood loss;Instrument performance evaluation;

Countries

China

Contacts

Public ContactZhang Yuan

Department of Orthopedics, the Second Affiliated Xinqiao Hospital, Army Medical University

joint_chueng@hotmail.com+86 13594010680

Outcome results

None listed

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