Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

NCT01383616 | Completed Phase 4 Results DMC

• 1 other identifier: 26033
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fracture

Keywords

osteoporosis; vertebral compression fractures

Outcome Measures

Primary Outcomes (2)

• Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups

  The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

  Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery

• Change in RDQ in the Bipedicular Group From 3 to 12 Months

  The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.

  3-12 months post operation

Secondary Outcomes (8)

• Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty

  Preoperative assessment within 3 weeks before surgery and postoperative day 1

• Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty

  Preoperative assessment within 3 weeks before surgery and postoperative day 1

• Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups

  3 months post-op

• Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups

  3 months post-op

• Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups

  12 months post-op

Study Arms (2)

Unipedicular kyphoplasty

ACTIVE COMPARATOR

Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.

Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

Bipedicular Kyphoplasty group

ACTIVE COMPARATOR

Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.

Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

Interventions

Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA) DEVICE

A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Bipedicular Kyphoplasty group; Unipedicular kyphoplasty

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brian Rebolledo, MD
• Organization: Hospital for Special Surgery

rebolledob@hss.edu

212-606-1172

Study Officials

• Tzipora Kuba, PhD

  Hospital for Special Surgery, New York

  STUDY DIRECTOR

• Joseph M Lane, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 28, 2011
• Study Start: July 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)