Evaluation of safety and effectiveness of the Osseofix Spinal Fracture Reduction System in treating spinal compression fractures

Completed

• Conditions: Acute vertebral compression fractures between levels T6 and L5; Musculoskeletal Diseases; Other disorders of bone density and structure

• Registration Number: ISRCTN26909676
• Lead Sponsor: Alphatec Spine (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-24
• Study Completion: 2013-11-01
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 21 years and above
2. Any male of female patients with vertebral fractures (1-3) caused by osteoporosis, multiple myeloma, or other osteolytic processes
3. Osteoporosis (primary or secondary)
4. Fracture levels between T6-L5
5. Pain VAS =4 (1-10)
6. Onset of pain within the last 3 months
7. Recent fractures with bone marrow signal changes on MRI
8. At least 15% decreased vertebral height compared with adjacent vertebrae
9. Progressive height loss or painful pseudoarthrosis
10. VCF morphology suitable for kyphoplasty

(Fracture types A1.1, A1.2, A1.3 and A 3.1 according to the AO classification)

Exclusion Criteria

1. Age < 21 years
2. Primary bone tumours
3. Osteoblastic metastases
4. Chronic (old) fractures (> 3 months)
5. Substantial clinical morbidities that preclude the patient from completing the protocol mandated follow-up or which may interfere with the study procedures
6. VCF morphology unsuitable for kyphoplasty (Pedicle fractures ,unstable burst fractures, spinal injuries in which the pedicles are dissociated from the vertebral body or spinal fractures in which posterior access to the vertebral body is not possible or contra-indicated.)
7. Neurologic deficit
8. Inability to complete follow up (medical, cognitive problems)
9. Prisoners
10. Pregnancy
11. Contraindications for MRI
12. Systemic or local Infection
13. Patients taking uninterruptive anticoagulation therapy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of life measures:<br>1.1. SF-36 Subscale score physical component summary PCS6<br>1.2. EuroQol 5 Dimention Questionnaire <br>2. Pain measures<br>2.1. Visual Analogue Scale (VAS)<br>2.2. SF-36 bodily pain<br>3. Function/Disability measures:<br>3.1. Oswestry disability Index (ODI) <br>3.2. Roland Morris disability questionnaire (RMDQ) <br>4. Complications/adverse events measures - clinical/related to a procedure or a device<br>5. Radiographic evaluation measures - vertebral height /shape, sagittal balance measurements

Secondary Outcome Measures

Name	Time	Method
1. Number of patients who received additional therapy post operation:<br>1.1. Physiotherapy<br>1.2. Walking aids<br>1.3. Back braces<br>1.4. Wheelchairs<br>1.5. Miscellaneous aids <br>1.6. Other therapy<br>2. Number of patients who use pain medications pre/ post op<br>3. Number of patients taking osteoporosis medications throughout the study<br>4. Fracture measures- fracture type: according to the AO classification Vertebral body involvement based on MRI findings 11 Presence of old vertebral fractures<br>5. Bone quality - DEXA scan to measure the BMD (assessment of osteoporosis/ osteopenia)<br>6. Procedure Measures<br>7. Size of implant used<br>8. Volume of cement used<br>9. Intraoperative radiation exposure<br>10. Duration of surgery