Clinical Trial: Scaphoid Non-union and Low-intensity Pulsed Ultrasound

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial Comparing Low-Intensity, Pulsed Ultrasound to Placebo in the Treatment of Operatively Managed Scaphoid Non-Unions

Brief Summary: This is a prospective, double-blind, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers within the Calgary zone will be involved in the study in order to recruit enough patients to power the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis.

Detailed Summary:

This is a prospective, double-blind, randomized controlled trial to determine the effectiveness of low-intensity pulsed ultrasound in decreasing the time to union of scaphoid non-unions after operative fixation as measured by serial CT scanning. Multiple centers within the Calgary zone will be involved in the study in order to recruit enough patients to power the study. Blinding will include patients, surgeons, research assistants, as well as all data handlers and analysts until trial completion or mid-term analysis. Baseline demographics including age, hand dominance, work status and medical co-morbidities of the patients will be collected to allow for comparison of the groups to ensure similarity.

Patients will be identified during clinic appointment for the initial consultation for surgical fixation of their scaphoid non-union. Patients consenting to surgical fixation will be assessed for inclusion and exclusion criteria and, if appropriate, will be consented and evaluated for baseline range of motion, grip strength, SF-36, DASH and both resting and activity VAS scores. Pre-operative radiographs will be assessed for the degree of wrist arthritis present. No restrictions will be placed on the selection or scheduling of surgical procedures, but the use of other adjuvants such as bone morphogenic protein will be limited.

Bioventus will provide visually identical active and sham Exogen 4000 units. The units will undergo randomization and will be given consecutively numbered labels. Devices will be securely stored at each clinical study center. All clinical centers and personnel involved will be blinded to the randomization. Two weeks post-operatively subjects will attend cast clinic and be assigned the next sequential device. The device will be applied through a window cut into the standardized cast with a center point over
Sponsor: University of Calgary

Current Primary Outcome: Time to radiographic union as evidenced on serial CT scans [ Time Frame: up to 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of union [ Time Frame: 8 weeks post-op ]
  • Percentage of union [ Time Frame: 12 weeks post-op ]
  • Rate of change of percent union [ Time Frame: 8-12 weeks, 12-16 weeks ]
  • Pattern of partial union on initial CT scan [ Time Frame: 8 weeks ]
  • Time to return to work [ Time Frame: up to 52 weeks ]
  • Functional outcomes as measured by range of motion and grip strength [ Time Frame: up to 52 weeks ]
    Range of motion measurements of wrist flexion/extension and forearm supination/pronation; grip strength using a grip dynamometer


Original Secondary Outcome: Same as current

Information By: University of Calgary

Dates:
Date Received: February 26, 2015
Date Started: September 2014
Date Completion:
Last Updated: August 22, 2016
Last Verified: August 2016