Percutaneous Vertebroplasty Versus Conservative Treatment in GIOPVCF

NCT03330340 | Unknown

• 1 other identifier: HSun-1
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

Based on the case reports and other literature, the investigators hypothesize that using PVP for treating GIOPVCF is associated with increased risk of vertebral refractures and does not provide further benefits compared to conservative treatments. The overall objective of this prospective cohort study is to compare the efficacy of PVP and conservative treatment for GIOPVCF. The evaluation of efficacy of therapy includes: 1) the incidence of vertebral refractures; 2) therapeutic effects (pain relief and health-related life quality) and 3) complications. The results from study will be written in English and disseminated widely through scholarly presentations, peer-reviewed publications, and other written communications.

Conditions

Osteoporosis

Keywords

vertebral compression fracture; osteoporosis; glucocorticoids; vertebroplasty

Outcome Measures

Primary Outcomes (1)

• Incidence of vertebral re-fracture

  Anterior-posterior and lateral spinal radiograph will be obtained. If a new vertebral fracture was doubted, MRI was undertaken to confirm it. When there is disagreement between both observers a consensus meeting is held. Incidence of vertebral re-fracture is Number of new fracture vertebrae/Number of total vertebrae

  12 months after the treatment

Secondary Outcomes (1)

• Visual Analog Scale (VAS) for back pain change from baseline to 12 months

  12 months after the treatment

Study Arms (2)

Percutaneous vertebroplasty

All PVPs are performed by experienced spine surgeons under optimal fluoroscopic guidance. The procedure takes place under sterile conditions. Local anesthesia is administered to the periosteum of the targeted pedicle via skin. Polymethylmethacrylate bone cement is injected under continuous fluoroscopic guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. Patients are encouraged to stand up and walk with brace immediately after operation and the brace are required to be worn for 3 months. Furthermore, all patients will take oral bisphosphonates treatment together with supplemental calcium and vitamin D.

Procedure: Percutaneous Vertebroplasty

Conservative treatment

In conservative treatment group, the patients were required horizontal bed rest for the initial 2 weeks after diagnosis. Then, they were encouraged to stand up and walk with brace and assistance. The bed rest time was extended if the back pain worsened when they stood up and walked. The brace should be worn in 3 months. For pain medication, nonsteroidal anti-inflammatory drugs (NSAIDs) were prescribed for every patient. Additional analgesics, such as tramadol and morphine, would be added in case NSAIDs were not effective. Two weeks after diagnosis, physical therapy was started. All patients are put on osteoporosis medication, bisphosphonates together with supplemental calcium and vitamin D.

Interventions

Percutaneous Vertebroplasty PROCEDURE

The procedure takes place under sterile conditions. Local anesthesia is administered from skin to the periosteum of the targeted pedicle. Polymethylmethacrylate bone cement (Mendec Spine; Tecres SPA, Sommacampagna, Italy) is injected under continuous fluoroscopic imaging guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. The amount of injected cement in each treated vertebral body and any cement leakage is recorded.

Percutaneous vertebroplasty

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients had fresh vertebral compression fractures with GIOP

You may qualify if:

• Patients have fresh vertebral compression fractures regarding spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone edema on MRI, focal tenderness on VCF level).
• Patients have back pain for 6 weeks or less, with a visual analogue scale (VAS) score equal or less than 5.
• GCs consumption for more than 3 months (prednisone equivalent or more than 5 mg daily).
• Reduced bone density with T-scores equal or less than -1.
• Age at 55 or higher.

You may not qualify if:

• Concurrent other secondary osteoporosis.
• Previous PVP procedure or other spinal surgery on thoracic or lumbar segments.
• Systemic or local infection in spine (osteomyelitis, spondylodiscitis)
• Unable to comply with study due to severe psychosis.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chunde Li, Doctor

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Haolin Sun, Doctor

CONTACT

+8613681146156; sunhaolin5@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 6, 2017

Record last verified: 2017-10