Clinical Trial: Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

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

Official Title: Safety and Efficacy of Botox Injection in Alleviating Post-Operative Pain and Improving Quality of Life in Lower Extremity Limb Lengthening and Deformity Correction

Brief Summary: The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

Detailed Summary:

The specific aims are to determine if BTX-A will:

  • 1a. Reduce pain post operatively and during the distraction and consolidation process,
  • 1b. Reduce the amount, frequency and duration of narcotics taken in the postoperative period.
  • 2. Improve the quality of life during the distraction and consolidation process.
  • 3 Decrease muscular spasm and subsequent muscle contracture during the distraction and consolidation process and accelerate earlier return to pre-operative mobility function including earlier weight bearing.
  • 4. To develop clinical practice guidelines for the interdisciplinary care of children undergoing limb lengthening or deformity correction.

Methodology: A randomization process for this one time injection will be used to determine who will receive the BTX-A or the placebo. 150 subjects will be recruited; 75 to the BTX-A group and 75 to the placebo group. There will be an equal number of subjects in each group at each site. The medication will be injected intraoperatively into specific major muscles in the lower limb adjacent to the bone or soft tissue being lengthened or corrected at a dose of 10 U/kg with a maximum of 50 U per site, not to exceed a total maximum dose of 400 units. Pain scores, medication dosages, range of motion and an ambulation scale will be measured post-operatively and during the distraction and consolidation phases.

In addition families will be asked to complete six different questionnaires related to pain, quality of life and psycho-social issues at various times during the process. The children will receive standard nursing care and physical therapy and will be fol
Sponsor: Shriners Hospitals for Children

Current Primary Outcome:

  • average pain scores in 1st 4 days post op [ Time Frame: 1st 4 days post op ]
  • total amount of narcotic used in 1st 4 days post op [ Time Frame: 1st 4 days post op ]


Original Primary Outcome:

  • average pain scores in 1st 4 days post op
  • total amount of narcotic used in 1st 4 days post op


Current Secondary Outcome:

  • Quality of life (PedsQL) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
  • Active and passive range of motion [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
  • Muscle strength [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]
  • Ambulation scores (FAQ) [ Time Frame: pre-op, mid distractionm end distraction, pre frame removal, 3 months post frame removal ]


Original Secondary Outcome:

  • Quality of life (PedsQL)
  • Active and passive range of motion
  • Muscle strength
  • Ambulation scores (FAQ)
  • Impact on family scores


Information By: Shriners Hospitals for Children

Dates:
Date Received: December 13, 2006
Date Started: January 2007
Date Completion:
Last Updated: December 22, 2014
Last Verified: December 2014