Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (Elbow HO)

This study has been completed.
Sponsor:
Collaborators:
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Greenville Hospital System University Medical Center
Virginia Commonwealth University
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00991887
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of heterotopic ossification.


Condition Intervention
Elbow Fracture
Radiation: Radiation Therapy (XRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • The primary radiographic outcome was the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes. [ Time Frame: 6 weeks, months 3 and 6 post-operatively ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2005
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Radiation Therapy (XRT)
This group will not receive radiation therapy after surgery.
Active Comparator: Radiation Therapy (XRT)
Radiotherapy will be administered no later than 72 hours postoperatively.
Radiation: Radiation Therapy (XRT)
The dose will be 700 cGy in a single fraction, using AP-PA fields calculated to midplane. No Less than 6MV energy photons will be used, and no bolus is placed on the skin. The field covers the entire joint, the antecubital fossa and the olecranon process. A strip of skin at the antecubital area is generally shielded, but is not an absolute requirement for this study.
Other Names:
  • XRT
  • Treatment group

Detailed Description:

A multi-institutional, prospective randomized clinical trial will be employed to determine if single dose, limited field radiation therapy (XRT) will prevent post-traumatic heterotopic ossification (HO) after open reduction internal fixation of intra-articular distal humerus fractures and fracture-dislocations of the elbow and to assess function of the elbow after XRT and no XRT. Patients will be randomly assigned to one of the two groups(XRT/treatment or no XRT/control) by a computer-generated randomization schedule. Assignment will be in a ratio of 1:1 in a complete block design of 10. Each clinical site will be provided with a separate randomization assignment for each study participant. The treating surgeon and patient will be blinded to group assignment until after operative treatment. Clinical and radiographic assessments at 6 weeks, 3 months and 6 months post-operatively will be performed. The primary clinical outcome will be the Mayo elbow performance score which measures pain, stability, function and motion. Motion parameters (flexion, extension, pronation and supination) will be performed at each data collection point. Primary radiographic outcome will be the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes at 6 weeks, 3 months, and 6 months post-operatively. Further imaging (radiograph or CT) will be obtained past the 6-month interval if deemed necessary by the treating physician,or if fracture union was not achieved at 6 months. The classification systems described by Brooker et al and Ilahi et al will be used to quantify the presence of HO by radiograph. All adverse events will be documented. The trial will be monitored periodically by the Safety Monitor at least twice a year to ensure protocol compliance and address safety issues.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Skeletally mature patients with minimum age of 18 years and maximum age of 65.
  • Patients deemed appropriate for operative intervention by the treating physician.
  • Distal humerus intra-articular fractures (types 13-C1, C2, and C3), with or without proximal radius/ulna fractures - open or closed.
  • Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed.

Exclusion Criteria:

  • Head injury, quantified by GCS < 13 at time of consent for operative intervention.
  • Burns > 20% TBA or involving the operative site.
  • Patients with spinal cord injury affecting the upper extremities will be excluded.
  • Open fractures which cannot be closed primarily within 72 hours of initial operative intervention.
  • Patients with estimated life expectancy of less than one year due to preexisting condition.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00991887

Sponsors and Collaborators
Carolinas Healthcare System
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Greenville Hospital System University Medical Center
Virginia Commonwealth University
Investigators
Principal Investigator: Michael J Bosse, MD Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: Michael J. Bosse, MD, Carolinas HealthCare System
ClinicalTrials.gov Identifier: NCT00991887     History of Changes
Other Study ID Numbers: 12-04-09A
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
OTA 13C1
OTA 13C2
OTA 13C3
OTA 21B1
OTA 21B2
OTA 21B3
OTA 21C1
OTA 21C2
OTA 21C3
Distal humerus intraarticular fractures with or without proximal radius/ulna fractures - open or closed
Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed

Additional relevant MeSH terms:
Ossification, Heterotopic
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014