Prospective, multicenter, randomized, open, parallel-controlled, noninferior-quality clinical trial to evaluate the efficacy and safety of orthopedic joint surgical navigation system

Conditions

Hip disease

Xianzuo Zhang, Xianyue Shen, Rongwei Zhang, Mo Chen, Ruixiang Ma et al. (9 authors)

Journal of Orthopaedics and Traumatology2024-06-2615 citations

Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty

Xianzuo Zhang, Shen Xianyue, Abasi Maimaitiabula, Zian Zhang, Haining Zhang et al. (7 authors)

Expert Review of Medical Devices2024-03-292 citations

10.1080/17434440.2024.2334932

Improved radiographic outcomes and decreased complications rate on the femoral side can be achieved by a novel designed whole-process robotic assisted hip system for total hip arthroplasty: a prospective randomized controlled trial.

Huang Z, Zhang Z, Wang W, Wang G, Lu X, Zhang H.

2024-02-162 citations

10.1007/s11701-024-01835-8

Prospective randomized controlled trial on the accuracy of prosthesis positioning in total hip arthroplasty assisted by a newly designed whole-process robotic arm.

Wang W, Zhang Z, Wang G, Rong C, Xu H, Lu X, Liu Y, Li C, Zhang H.

2022-07-0813 citations

10.1007/s00264-022-05501-2

Interventions

Experimental Group:THA with TRex-RS

Control:THA in traditional way

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Subjects voluntarily participate in the study and sign the informed consent; 2) Age 18 to 75 (including 18 and 75), gender is not limited; 3) Patients requiring total hip replacement; 4) Those who can communicate well with the investigator and follow the requirements of the experiment. Those who do not meet any of the above criteria will not be selected.

Exclusion criteria

Exclusion criteria: 1) Patients with allergy to medication or implant material in this study; 2) immature bone development; 3) Active infection; 4) Hip neuropathy; 5) Poor bone mass is not conducive to the fixation of biological prosthesis; 6) Systemic conditions or associated diseases make it difficult to tolerate surgery; 7) Insufficient muscle strength of the hip; 8) Pathologically obese, BMI > 35; 9) Insufficient bone mass of the greater trochanter or insufficient skin coverage nearby, intolerant to surgery; 10) Severe femoral or pelvic deformity and other severe extrarticular deformity; 11) The presence of metal implants in the joint surgery area affects the execution of the operation plan; 12) Pregnant or lactating women; 13) Suffering from severe epilepsy or mental illness; 14) alcohol dependence or drug addiction; 15) Patients with severe coagulation dysfunction; 16) Participants who have participated in or are participating in other clinical trials within one month at the time of inclusion; 17) Those who are considered by the investigator to be unsuitable to participate in the clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.

Design outcomes

Primary

Measure	Time frame
Implantation success rate;	—

Secondary

Measure	Time frame
Preoperative navigation preparation time and operative time;Incision length and intraoperative blood loss;Postoperative imaging indexes;Hip fuction;Software evaluation;Operational satisfaction;	—

Countries

China

Contacts

Public ContactHaining Zhang

Affiliated Hospital of Qingdao University

zhhaining@hotmail.com+86 18661800365

Outcome results

None listed