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Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study (SP-Pilot)

Primary Purpose

Tibial Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suprapatellar approach
Infrapatellar approach
Sponsored by
Florida Orthopaedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring tibia, suprapatellar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital
  • St. Josephs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Suprapatellar approach

Infrapatellar approach

Arm Description

surgical approach for intramedullary nailing of the tibia

surgical approach for intramedullary nailing of the tibia

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

union/alignment of tibia
AP and lateral radiographs will be used to evaluate union/alignment of the tibia.
knee function
A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.
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.

Full Information

First Posted
April 20, 2011
Last Updated
February 13, 2017
Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association
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1. Study Identification

Unique Protocol Identification Number
NCT01341418
Brief Title
Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study
Acronym
SP-Pilot
Official Title
Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
tibia, suprapatellar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprapatellar approach
Arm Type
Active Comparator
Arm Description
surgical approach for intramedullary nailing of the tibia
Arm Title
Infrapatellar approach
Arm Type
Active Comparator
Arm Description
surgical approach for intramedullary nailing of the tibia
Intervention Type
Procedure
Intervention Name(s)
Suprapatellar approach
Other Intervention Name(s)
semi-extended approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infrapatellar approach
Other Intervention Name(s)
standard tibial nailing approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
residual postoperative knee pain
Description
A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
union/alignment of tibia
Description
AP and lateral radiographs will be used to evaluate union/alignment of the tibia.
Time Frame
3 months postoperatively
Title
knee function
Description
A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.
Time Frame
6 months postoperatively
Title
trochlear changes in the patello-femoral cartilage
Description
Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy W Sanders, M.D.
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Josephs Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20926959
Citation
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.
Results Reference
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Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

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