INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia (INSURT)

F

Fraser Orthopaedic Research Society

Status

Completed

Conditions

Anterior Knee Pain Syndrome
Tibial Fractures

Treatments

Procedure: Infrapatellar Approach
Procedure: Suprapatellar Approach

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02750072
FHREB #: 2016-029

Details and patient eligibility

About

This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.

Full description

There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation. 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.

Enrollment

248 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all extra-articular tibial fractures
  • 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 femur and/or hip fracture requiring retrograde IMN
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

248 participants in 2 patient groups

Infrapatellar approach
Active Comparator group
Description:
Infrapatellar approach using the surgeon's incision of choice (i.e., patellar tendon split, tendon retraction medial, tendon retraction lateral).
Treatment:
Procedure: Infrapatellar Approach
Semi-extended suprapatellar approach
Experimental group
Description:
Semi-extended suprapatellar approach using quadriceps split combined with purpose designed suprapatellar percutaneous instrumentation (patellofemoral protection sleeve).
Treatment:
Procedure: Suprapatellar Approach

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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