Clinical trial NCT01383616: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Official title: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vertebral Compression Fracture
Keywords: osteoporosis
vertebral compression fractures
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.


Eligibility criteria: Inclusion Criteria:

* Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.

Exclusion Criteria:

* primary tumors of bone or evidence of metastasis at the index vertebrae
* pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
* fracture secondary to a traumatic event
* inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy

Primary outcomes:
measure: Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery
measure: Change in RDQ in the Bipedicular Group From 3 to 12 Months
timeFrame: 3-12 months post operation
Secondary outcomes:
measure: Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty
timeFrame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
measure: Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty
timeFrame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
measure: Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: 3 months post-op
measure: Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: 3 months post-op
measure: Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: 12 months post-op
measure: Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: 12 months post-op
measure: Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
timeFrame: 12 months post-op
measure: Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty
timeFrame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Tzipora Kuba, PhD
role: STUDY_DIRECTOR
affiliation: Hospital for Special Surgery, New York
name: Joseph M Lane, MD
role: PRINCIPAL_INVESTIGATOR
References: