Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

Tibial Fractures Clinical Trial

— SP-Pilot  

Official title:

Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341418
• Other study ID #: SP-2676-3103
• Secondary ID: OTA 39
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: February 13, 2017
• Start date: April 2011
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.

Description:

Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming

• Acute tibial fractures within 4 weeks of injury

• Closed or open tibial fractures after appropriate irrigation and debridement

• Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia

• Skeletally mature patient

• Age 18 and above.

Exclusion Criteria:

• Tibial shaft fractures that require articular reconstruction with plates

• Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia

• Tibial plateau fractures

• Pilon fractures

• Periprosthetic fractures

• Non-unions

• Prior knee surgery

• History of gout or rheumatoid or osteoarthritis

• Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)

• Spinal injury

• Prisoner or high likelihood of incarceration

• Not likely to follow-up in the estimation of surgeon

• Pregnant females

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Procedure:
• Suprapatellar approach
Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
• Infrapatellar approach
The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.

Locations

Country	Name	City	State
United States	St. Josephs Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gelbke MK, Coombs D, Powell S, DiPasquale TG. Suprapatellar versus infra-patellar intramedullary nail insertion of the tibia: a cadaveric model for comparison of patellofemoral contact pressures and forces. J Orthop Trauma. 2010 Nov;24(11):665-71. doi: 10.1097/BOT.0b013e3181f6c001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual postoperative knee pain	A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.	1 year
Secondary	union/alignment of tibia	AP and lateral radiographs will be used to evaluate union/alignment of the tibia.	3 months postoperatively
Secondary	knee function	A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.	6 months postoperatively
Secondary	trochlear changes in the patello-femoral cartilage	Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.	1 year