ClinicalTrials.Veeva

Menu

Suprapatellar Nailing of Tibial Shaft Fractures

S

Spectrum Health Hospitals

Status

Completed

Conditions

Broken Leg

Study type

Observational

Funder types

Other

Identifiers

NCT02728362
2016-027

Details and patient eligibility

About

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

Full 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

Enrollment

38 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems