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Suprapatellar Nailing of Tibial Shaft Fractures

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ClinicalTrials.gov Identifier: NCT02728362
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

Brief Summary:
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.

Condition or disease
Broken Leg

Detailed Description:

Suprapatellar nailing...

Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.

Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.

Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:

  1. To evaluate the long term presence of knee pain
  2. To evaluate the long term functional outcomes

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up
Study Start Date : April 2016
Estimated Primary Completion Date : April 2028
Estimated Study Completion Date : April 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures




Primary Outcome Measures :
  1. Long term presence of knee pain [ Time Frame: 10 years ]
    During follow up visits participants will be administered the Visual Analog Scale (VAS) and the Patient Reported Outcomes Measurement Information System (PROMIS) Pain intensity short form 3a and Pain interference short form 8a. These forms will be analyzed together to determine an overall presence of knee pain.


Secondary Outcome Measures :
  1. Long term functional outcomes [ Time Frame: 10 years ]
    During follow up visits participants will be administered the Lysholm knee score and the PROMIS Mobility measure. These forms will be analyzed together to determine the overall long term function of the participants.

  2. Knee Range of Motion (ROM) [ Time Frame: 10 years ]
    During follow up visits the participants knee ROM will be measured

  3. Fracture Healing [ Time Frame: 10 years ]
    During follow up visits fracture healing will be evaluated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with tibial shaft fractures.
Criteria

Inclusion Criteria:

  • Isolated, unilateral tibial shaft fractures
  • Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
  • age 18-65, including pregnant women
  • open or closed fractures
  • able to sign consent
  • english speaking

Exclusion Criteria:

  • compartment syndrome
  • other lower extremity injuries that will affect functional outcomes
  • problems maintaining follow up (homeless, not willing to return for follow up)
  • pathological fractures
  • prisoners
  • previous retained hardware in the injured leg
  • injuries requiring vascular repair

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728362


Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Blake W Miller, DO Spectrum Health Hospitals
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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02728362    
Other Study ID Numbers: 2016-27
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Spectrum Health Hospitals:
tibial shaft fractures
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries