NCT03724422

Brief Summary

To determine the effectiveness of 500 cGy dose of radiation therapy vs. an untreated group in the prophylactic treatment of heterotopic ossification in distal humerus fractures

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 9, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2022

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

September 20, 2018

Results QC Date

December 14, 2021

Last Update Submit

January 25, 2022

Conditions

Heterotopic OssificationHumeral FracturesRadiation Therapy

Keywords

Herteropic Ossification

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Presence of HO on Humerus

    Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham

    1 year. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days.

Secondary Outcomes (1)

  • Non-union at the Fracture Site.

    1 year post surgical reduction. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days respectively.

Study Arms (2)

Control

NO INTERVENTION

This group will receive the standard of care treatment for their distal humerus fracture only.

Intervention

EXPERIMENTAL

This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.

Radiation: Radiation

Interventions

RadiationRADIATION

A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a distal humerus fracture.
  • Patient's age is greater than or equal to 18

You may not qualify if:

  • Patient has a concomitant proximal ulna and/or proximal radius fracture
  • Patient requires external fixation of the elbow
  • Patient has quadriplegia or paraplegia
  • Patient requires intubation upon admission or for \>4 hours during admission for nonsurgical purposes
  • Patient has concomitant soft tissue damage in the affected elbow that cannot be appropriately closed within 72 hours of surgery
  • Patient has a burn affecting greater than or equal to 20% of the total body surface area or on the affected elbow
  • Patient has pre-existing heterotopic ossification in the affected elbow.
  • Patient is pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40228, United States

Location

Related Publications (9)

  • Ranganathan K, Loder S, Agarwal S, Wong VW, Forsberg J, Davis TA, Wang S, James AW, Levi B. Heterotopic Ossification: Basic-Science Principles and Clinical Correlates. J Bone Joint Surg Am. 2015 Jul 1;97(13):1101-11. doi: 10.2106/JBJS.N.01056.

    PMID: 26135077BACKGROUND

  • Kaplan FS, Glaser DL, Hebela N, Shore EM. Heterotopic ossification. J Am Acad Orthop Surg. 2004 Mar-Apr;12(2):116-25. doi: 10.5435/00124635-200403000-00007.

    PMID: 15089085BACKGROUND

  • Foruria AM, Lawrence TM, Augustin S, Morrey BF, Sanchez-Sotelo J. Heterotopic ossification after surgery for distal humeral fractures. Bone Joint J. 2014 Dec;96-B(12):1681-7. doi: 10.1302/0301-620X.96B12.34091.

    PMID: 25452373BACKGROUND

  • Abrams GD, Bellino MJ, Cheung EV. Risk factors for development of heterotopic ossification of the elbow after fracture fixation. J Shoulder Elbow Surg. 2012 Nov;21(11):1550-4. doi: 10.1016/j.jse.2012.05.040. Epub 2012 Sep 2.

    PMID: 22947234BACKGROUND

  • Davis JA, Roper B, Munz JW, Achor TS, Galpin M, Choo AM, Gary JL. Does Postoperative Radiation Decrease Heterotopic Ossification After the Kocher-Langenbeck Approach for Acetabular Fracture? Clin Orthop Relat Res. 2016 Jun;474(6):1430-5. doi: 10.1007/s11999-015-4609-y.

    PMID: 26497882BACKGROUND

  • Robinson CG, Polster JM, Reddy CA, Lyons JA, Evans PJ, Lawton JN, Graham TJ, Suh JH. Postoperative single-fraction radiation for prevention of heterotopic ossification of the elbow. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1493-9. doi: 10.1016/j.ijrobp.2009.06.072.

    PMID: 20637977BACKGROUND

  • Heyd R, Strassmann G, Schopohl B, Zamboglou N. Radiation therapy for the prevention of heterotopic ossification at the elbow. J Bone Joint Surg Br. 2001 Apr;83(3):332-4. doi: 10.1302/0301-620x.83b3.11428.

    PMID: 11341414BACKGROUND

  • Stein DA, Patel R, Egol KA, Kaplan FT, Tejwani NC, Koval KJ. Prevention of heterotopic ossification at the elbow following trauma using radiation therapy. Bull Hosp Jt Dis. 2003;61(3-4):151-4.

    PMID: 15156818BACKGROUND

  • Hamid N, Ashraf N, Bosse MJ, Connor PM, Kellam JF, Sims SH, Stull DE, Jeray KJ, Hymes RA, Lowe TJ. Radiation therapy for heterotopic ossification prophylaxis acutely after elbow trauma: a prospective randomized study. J Bone Joint Surg Am. 2010 Sep 1;92(11):2032-8. doi: 10.2106/JBJS.I.01435.

    PMID: 20810853BACKGROUND

MeSH Terms

Conditions

Ossification, HeterotopicHumeral Fractures

Interventions

Radiation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

Title
Salwa Rashid
Organization
University of Louisville
salwa.rashid@louisville.edu
5028526964

Study Officials

  • Rodolfo Zamora, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either a treatment or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

September 20, 2018

First Posted

October 30, 2018

Study Start

October 9, 2019

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

February 15, 2022

Results First Posted

February 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

No plan at this time to Share IPD

Locations

US(2)