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Clinical Efficacy and Safety of the Decision Model Based on CT Value for Pedicle Screw in Patients with Osteoporosis: A Single Centre, Prospective, Randomised Controlled Trial

Clinical Efficacy and Safety of the Decision Model Based on CT Value for Pedicle Screw in Patients with Osteoporosis: A Single Centre, Prospective, Randomised Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047652
Enrollment
Unknown
Registered
2021-06-21
Start date
2021-06-30
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

osteoporosis

Interventions

experimental group:bone cement pedicle screw fixation
Control group:Conventional treatment

Sponsors

Department of Orthopaedic, Tangdu Hospital, Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative dual energy X-ray bone mineral density showed osteoporosis; 2. The subject or guardian is willing and able to sign the informed consent before operation; 3. Patients aged 50-80 years (including 50 and 80 years), no gender limitation; 4. Patients with lumbosacral problems (L1-L5/S1) who have experienced at least 4-6 weeks of unsuccessful non-surgical conservative treatment (except those with urgent needs after trauma) and need spinal interbody fusion; 5. There was no operation contraindication in routine laboratory test and examination before operation; 6. Good compliance, being willing and able to follow up as required.

Exclusion criteria

Exclusion criteria: 1. Severe local or systemic infection, such as osteomyelitis; 2. Any psychiatric or neuromuscular or vascular disorder that may result in an unacceptable risk of fixation failure or complications during postoperative care; 3. Excluded patients with systemic or metabolic diseases, hypertension and diabetes controlled within normal limits; 4. Excluded patients with obesity leading to implant fixation failure or implantation materials damaged by overloading; 5. Patients are unwilling to follow the instructions of postoperative therapy and/or rehabilitation program; mental illness, drug abuse or alcoholism; it cannot guarantee the patients to quit smoking during fracture healing period; 6. Due to diseases, infections or previous surgical procedures, the existing bone mass cannot provide enough support and/or fixation for the implant device and affect osseous fusion; 7. Spinal tumors, including bone metastases; patients undergoing radiotherapy; 8. Long-term use of drugs that affect bone and soft tissue healing (such as chemotherapy drugs, corticosteroids, except methylprednisolone); Use of growth factors, long-term use of sedative hypnotics (continuous use for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); 9. Subjects had other medical conditions that limited their participation in the study, could not comply with follow-up or affected the scientific integrity of the study.

Design outcomes

Primary

MeasureTime frame
CT value;

Countries

China

Contacts

Public ContactLi Xiaoxiang

Department of Orthopedics, Tangdu Hospital, Air Force Military Medical University

junyixiangzi@163.com+86 15929779234

Outcome results

None listed

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