INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
NCT ID: NCT02750072
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2016-09-13
2023-10-12
Brief Summary
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Detailed Description
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The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Infrapatellar approach
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Infrapatellar Approach
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Semi-extended suprapatellar approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Suprapatellar Approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
Interventions
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Infrapatellar Approach
Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
Suprapatellar Approach
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
Eligibility Criteria
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Inclusion Criteria
* simple distal tibial intra-articular fractures amenable to IMN
* open and closed fractures
* bilateral tibiae
* willing and able to consent, follow protocol and attend follow-up visits
* able to read and understand English or have interpreter available
Exclusion Criteria
* patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
* associated knee injury
* previous symptomatic knee pathology
* ipsilateral injuries to the same limb that would interfere with rehab or outcome
* neurovascular injuries at the level of the knee requiring surgery
* open or closed fractures \> 14 days (times of injury to OR)
* non unions
* pathologic fractures
* periprosthetic fractures
* spinal injury
* non-ambulatory patients
* incarceration
* limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
* likely problems, in the judgment of the investigators, with maintaining follow-up
18 Years
65 Years
ALL
No
Sponsors
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Fraser Orthopaedic Research Society
NETWORK
Responsible Party
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Principal Investigators
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Darius G Viskontas, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital / Fraser Health Authority
Trevor B Stone, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Royal Columbian Hospital / Fraser Health Authority
Alan Johnstone, Professor
Role: PRINCIPAL_INVESTIGATOR
Aberdeen Royal Infirmary
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Columbian Hospital / Fraser Health Authority
New Westminster, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Karachalios T, Babis G, Tsarouchas J, Sapkas G, Pantazopoulos T. The clinical performance of a small diameter tibial nailing system with a mechanical distal aiming device. Injury. 2000 Jul;31(6):451-9. doi: 10.1016/s0020-1383(00)00024-3.
Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg Am. 2002 Apr;84(4):580-5. doi: 10.2106/00004623-200204000-00011.
Katsoulis E, Court-Brown C, Giannoudis PV. Incidence and aetiology of anterior knee pain after intramedullary nailing of the femur and tibia. J Bone Joint Surg Br. 2006 May;88(5):576-80. doi: 10.1302/0301-620X.88B5.16875. No abstract available.
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Koval KJ, Clapper MF, Brumback RJ, Ellison PS Jr, Poka A, Bathon GH, Burgess AR. Complications of reamed intramedullary nailing of the tibia. J Orthop Trauma. 1991;5(2):184-9. doi: 10.1097/00005131-199105020-00011.
Ryan SP, Steen B, Tornetta P 3rd. Semi-extended nailing of metaphyseal tibia fractures: alignment and incidence of postoperative knee pain. J Orthop Trauma. 2014 May;28(5):263-9. doi: 10.1097/BOT.0000000000000083.
Jones M, Parry M, Whitehouse M, Mitchell S. Radiologic outcome and patient-reported function after intramedullary nailing: a comparison of the retropatellar and infrapatellar approach. J Orthop Trauma. 2014 May;28(5):256-62. doi: 10.1097/BOT.0000000000000070.
Vaisto O, Toivanen J, Paakkala T, Jarvela T, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of a tibial shaft fracture: an ultrasound study of the patellar tendons of 36 patients. J Orthop Trauma. 2005 May-Jun;19(5):311-6.
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Morandi M, Banka T, Gaiarsa GP, Guthrie ST, Khalil J, Hoegler J, Lindeque BG. Intramedullary nailing of tibial fractures: review of surgical techniques and description of a percutaneous lateral suprapatellar approach. Orthopedics. 2010 Mar;33(3):172-9. doi: 10.3928/01477447-20100129-22. No abstract available.
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Other Identifiers
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FHREB #: 2016-029
Identifier Type: -
Identifier Source: org_study_id
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