RecruitingACTRN12620000109909

Evaluating outcomes of above-knee versus below-knee nailing of tibial shaft fractures.

Evaluating functional outcomes of suprapatellar versus infrapatellar approach for intramedullary nailing of tibial shaft fractures.


Sponsor

A/Prof Mark Rickman

Enrollment

60 participants

Start Date

Aug 1, 2020

Study Type

Interventional

Conditions

Summary

Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, but the surgical approach may play an important role. The central aim of this study is to conduct a pilot randomised controlled trial (RCT) investigating the influence of surgical approach (suprapatellar nailing (SPN) versus infrapatellar nailing (IPN)) on tibial shaft fractures treated with intramedullary nailing, via development of a biomechanically validated methodology for assessing post-operative anterior knee pain and functional patient outcomes. This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital (South Australia). We aim to recruit a total of 60 patients between the ages of 18 – 60 years old, who will be randomly assigned to one of the approaches after a decision has been made for surgical fixation. All nails used in this study will be Stryker T2 Alpha nails. Patients will be followed up to 18 months after surgery, and will complete a number of patient-reported outcome measures and functional movement and gait assessments in the Gait Lab at Clinical Research Facility located in the Adelaide Health and Medical Sciences Building. This study will help to provide clarity on the effect of SPN versus IPN for intramedullary nailing of tibial shaft fractures. We hypothesize that there is a difference in clinical and functional outcomes between patients managed suprapatellar or infrapatellar intramedullary nailing approaches.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria3

  • – 60 years old at the time of inclusion;
  • Unilateral, extra-articular, tibial shaft fractures;
  • Intramedullary fixation is the preferred treatment of the fracture as determined by the surgeon on call

Exclusion Criteria7

  • Unable to write or read English;
  • Unable to understand spoken English;
  • Unable to give informed consent;
  • Fractures involving the tibial metaphysis (upper ¼ of the tibia);
  • Other major trauma to the lower limbs (except for ipsilateral fibular fractures);
  • ASA-classification of 3 or more at the time of inclusion;
  • Pre-existing musculoskeletal disorders associated with mobility problems or impaired functioning of the lower limbs.

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Interventions

Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, b

Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, but the surgical approach may play an important role. This study will compare suprapatellar nailing versus infrapatellar nailing of tibial shaft fractures. Infrapatellar nailing is an extra-articular approach, where the nail is inserted below the patella. Infrapatellar nailing can be performed transtendinous, whereby the patella tendon is split, or by lateral or medial retraction of the patella tendon (lateral or medial parapatellar approach) with the knee in a flexed or hyper-flexed position. Suprapatellar nailing is an intra-articular technique, where the nail is inserted from above the patella using a quadriceps incision. Suprapatellar nailing allows the knee to remain in an extended position. Existing methodologies used to assess the outcomes of tibial shaft fracture patients treated with intramedullary nailing have yet to be biomechanically validated, and the optimal intramedullary nailing technique based on patient satisfaction remains unknown and requires further study. This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital (South Australia). We aim to recruit a total of 60 patients between the ages of 18 – 60 years old, who will be randomly assigned to one of the approaches after a decision has been made for surgical fixation. Patients who do not consent to the study will not be included and will receive standard clinical care. For patients consenting to the study, we will follow the patients up to 18 months post-operatively to compare the outcomes between groups. Patients will undergo surgery after fracture at times in line with local protocols, and the surgery will be performed by the normal surgical team at the hospital for that day. No changes to timings or personnel will be made. Post-operatively, all patients will be mobilised and fully weight bearing as able and will follow standard physiotherapy and rehabilitation regimes. Each surgery will be conducted by an orthopaedic surgeon and will take approximately 30 – 45 minutes. Fidelity of the procedure is assessed by radiographic image intensifier by the orthopaedic surgical team operating that day, as is standard clinical care. All nails used in this study will be Stryker T2 Alpha nails.


Locations(2)

The Royal Adelaide Hospital - Adelaide

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

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ACTRN12620000109909


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