Clinical Trials Logo
  1. Home
  2. Tibial Fractures
  3. NCT01797640
  4. Details
NCT01797640 Clinical Trial

Intramedullary Nailing of Tibia Fractures

Tibial Fractures Clinical Trial

Official title:
Intramedullary Nailing of Tibia Fractures in the Presence of Medial or Posterior Malleolar Fractures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01797640
Other study ID # 50553
Secondary ID
Status Completed
Phase N/A
First received January 4, 2013
Last updated July 8, 2015
Start date October 2012
Est. completion date April 2015

Study information
Verified date July 2015
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- All patients, 18+ years of age, that have been treated at the University of Utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Utah Orthopedics Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Malleolar involvement in tibial fracture Currently the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. 6 Week Post-Op No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05459038 - Clinical Validation of the C-Arm Rotational View (CARV) to Avoid Rotational Malalignment After Intramedullary Nailing of Tibial Shaft Fractures. N/A
Terminated NCT02845245 - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques N/A
Completed NCT02456194 - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial N/A
Completed NCT01132508 - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures N/A
Terminated NCT00667849 - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures N/A
Completed NCT00512434 - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture N/A
Completed NCT00161616 - Study Evaluating InductOs in Diaphyseal Tibia Fractures Phase 4
Terminated NCT03881241 - Safety Study of Treatment of Leg Fractures
Completed NCT02750072 - INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia N/A
Completed NCT04015167 - A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
Completed NCT05613257 - Distal Targeter vs Free-hand N/A
Completed NCT03388879 - Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures N/A
Completed NCT02491047 - Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures N/A
Recruiting NCT03232216 - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate? N/A
Withdrawn NCT03826784 - Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures Phase 3
Terminated NCT00253981 - Light Therapy in the Treatment of Leg Pain N/A
Completed NCT05303389 - Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures N/A
Recruiting NCT05272631 - Depuy Synthes Lower Extremity Shaft Nail Registry
Completed NCT03540719 - Surgical Management of Posterior Tibial Plateau Fractures
Completed NCT03166267 - Real Life Weight Bearing After Tibial Fractures