Clinical Trial: Vertebroplasty Compared With a Sham-procedure for Painful Acute Osteoporotic Vertebral Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Randomized Study for Comparison of Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vert

Brief Summary:

The main purpose of this study:

- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.

Secondary purposes:

  • To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
  • measure if there are differences in change of lung capacity between the two methods

Detailed Summary:

The objective of this study is to evaluate the efficacy of bone cement injection (PVP) for patients with acute painful osteoporotic compression fractures, as compared with a simulated procedure with injection of Lidocaine. Our hypothesis is, that patients who had undergone PVP would report less pain during the first 1-12 weeks and at 12 months (primary outcomes) than those in the sham control group.

The study design of VOPE is a single center double blinded RCT concerning the treatment of patients with a painful osteoporotic VCF. Patients are referred to the principal investigator at Middelfart hospital from the emergency rooms, orthopedics departments, GP's and chiropractors from the Region of Southern Denmark. Prior to enrolling patients randomization-envelopes are constructed in blocks of 20. Upon obtaining informed consent, a study-number is assigned to each patient. The final randomization for each patient, takes place in the operation room upon opening the sealed envelope deciding which of the two operations are to be performed. A total of 80 patients will be enrolled, 40 in each group. This is based on the assumption of a 2.0 point difference in pain relief (VAS Score) and a maximum of 35% withdrawal rate (α=0.05 and β=0.20). The enrolment of patients will take place in a single center, the spine surgery department of Middelfart hospital in Denmark. Randomization will start February 2012 with an expected completion of enrolment by May 2013. There is a one-year follow-up, with the possibility of an extended follow-up at two years.

The overall Institutional Review Board approval is obtained at Middelfart Hospital.

Osteoporosis- and pain medication:

All patients are, in cooperation with the osteoporosis clinic
Sponsor: Sygehus Lillebaelt

Current Primary Outcome: Pain relief [ Time Frame: 12 Months ]

Primary outcome will be pain relief at 1 day, 1-12 weeks, and 12 months. The questionnaire consist of the VAS score and questions about use, ammount and type of pain medication. Patients are asked to fill out the VAS and NRS score, and use of analgesics is recorded once every week during the first 3 months after randomization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 12 months ]
    Quality of life as meassured with the EuroQol 5D questionnaire at 3 and 12 months. It consists of 5 different questions.
  • Physical function, disability etc. [ Time Frame: 12 months ]
    The patients fill out the SF-36 questionnaire at baseline and at 3 and 12 months. It consists of 36 questions containing 8 domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning,emotional role functioning, social role functioning, mental health.
  • Lung capacity [ Time Frame: 12 months ]
    Lungcapacity as examined with a spirometer at 3 and 12 months. The patients history of lungdiseases and use of medicin affecting the lungcapacity is registered at baseline and at 3 and 12 months.
  • Subsidence of the affected vertebral bodies and local kyphosis [ Time Frame: 12 ]
    X-ray images of the entire spine, lateral view at 3 and 12 months.


Original Secondary Outcome: Same as current

Information By: Sygehus Lillebaelt

Dates:
Date Received: February 17, 2012
Date Started: February 2012
Date Completion:
Last Updated: September 10, 2015
Last Verified: October 2014