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A clinical verification study of the bone strength measurement instrument based on force perception and a study on the scheme of the orthopedics surgery on patient with osteoporosis

A clinical verification study of the bone strength measurement instrument based on force perception and a study on the scheme of the orthopedics surgery on patient with osteoporosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064662
Enrollment
Unknown
Registered
2022-10-13
Start date
2022-10-01
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

Osteoporosis

Interventions

Case series:None

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. At least one of the following: (1) Need for spinal surgery including pedicle screw placement; (2) Meet the surgical indications for artificial femoral head replacement, plan to perform artificial femoral head replacement, and the discarded femoral head has no other clinical uses; (3) Suffering from distal radius fracture, proximal humerus fracture, or ankle fracture, minimally invasive or open surgery is planned, and the surgical plan includes nail placement; 2. ASA classification of the American Society of Anesthesiologists is I~II; 3. The subjects are willing and able to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient is mentally incapable or unable to understand the requirements of participating in the research; 2. People with metal allergy, allergic constitution or allergic to multiple drugs; 3. Pregnant and lactating women; 4. The subject is unwilling or unable to restrict activities or follow doctor's orders; 5. Those who are in critical condition, the expected survival period is less than 2 years, and it is difficult to make an exact evaluation of the effectiveness and reliability of the device.

Design outcomes

Primary

MeasureTime frame
Contact force & torque during nail placement;

Secondary

MeasureTime frame
T score (DXA);Z score (DXA);

Countries

China

Contacts

Public ContactYu Zhao

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

zhaoyupumch@163.com+86 15601089898

Outcome results

None listed

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