An observational study in Broken Leg, sponsored by Spectrum Health Hospitals. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Spectrum Health Hospitals · Observational
To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.
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:
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Spectrum Health Hospitals is the lead sponsor of 38 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting with tibial shaft fractures.
Exclusion Criteria:
Long term presence of knee pain
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.
Time frame: 10 years
Long term functional outcomes
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.
Time frame: 10 years
Knee Range of Motion (ROM)
During follow up visits the participants knee ROM will be measured
Time frame: 10 years
Fracture Healing
During follow up visits fracture healing will be evaluated
Time frame: 10 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Spectrum Health Hospitals