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Completed

NCT Number: NCT02728362

Suprapatellar Nailing of Tibial Shaft Fractures

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

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Key information

Conditions

Broken Leg

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • To evaluate the long term presence of knee pain
  • To evaluate the long term functional outcomes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2016
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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