Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures

Browse trials for

• Fractures, Bone 2,261

Keywords

• External ring fixation
• Intramedullary nailing
• Tibial shaft fracture
• patient reported outcome

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 67 is close to the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Lead sponsor

Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.

Study arms

• Active comparator
  Intramedullary Nail

  Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.

  Procedure: Intramedullary Nailing

• Experimental
  External Ring fixator

  External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.

  Procedure: External Ring fixation

Interventions

• ProcedureIntramedullary Nailing

  fracture fixation of the tibial shaft fracture with an intramedullary nail.

• ProcedureExternal Ring fixation

  fracture fixation of the tibial shaft fracture with an external ring fixator.

Primary outcomes

1. The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)

   KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

   Time frame: 12 month follow up

Secondary outcomes

1. Perceived Pain

   Development in pain in the two groups will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.

   Time frame: 6 weeks, 3+6+12 months

2. Patient-reported pain reactions

   Pain DETECT questionnaire. The painDETECT screening questionnaire (PD-Q), uses a scoring method between - 1 and 38 to estimate the likelihood of a neuropathic pain component in patients.

   Time frame: 6 weeks, 3+6+12 months

3. Pain sensitivity

   Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).

   Time frame: 6 weeks, 3+6+12 months

4. Muscle strength

   Isometric muscle strength in the two groups will be measured by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK). Girth measures of thigh and calf will be used to examine muscle atrophy and/or effusion

   Time frame: 6+12 months

5. Time to bone union

   Bone union, in the two surgical groups will be evaluated on standard AP and side X-rays of the fractured leg. The evaluation of bone union will be defined as: i) visible callus formation on at least three of four sides, no visible fracture line and no pain from fracture site at weight-bearing and during clinical examination.

   Time frame: 6 weeks, 3+6+12 months

6. Radiological alignment

   Alignment of the tibia will be evaluated using the EOS scanning system.

   Time frame: 6 weeks, 3+6+12 months

7. Health related QOL

   Eq5D-5L is a standardized questionnaire developed to assess general health outcome (29). It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death

   Time frame: 6 weeks, 3+6+12 months

8. Time to return to work

   Measure the time from surgery to end of sick leave measured in days.

   Time frame: 6 weeks, 3+6+12 months

9. Health economic evaluation

   Measure the cost of treatment in the two groups within the first year following surgery

   Time frame: 12 months

10. Gait assessment

    Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.

    Time frame: 3+6+12 months

11. Patient Acceptable Symptom State (PASS)

    This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment

    Time frame: 3+6+12 months

12. The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    KOOS is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems.The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

    Time frame: 6 weeks, 3+6+12 months

13. Foot And Ankle Outcome Score (FAOS)

    FAOS is a standardized and validated patient-reported instrument used in order to assess foot and ankle associated problems divided into 5 subscales. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

    Time frame: 6 weeks, 3+6+12 months

Other outcomes

1. Adverse events

   Adverse events, defined as any negative or unwanted reactions to the two surgical procedures, will be recorded. These will include deep infection, pin infection, skin infections, malalignment, compartment syndrome or any other reported physical discomfort. An adverse effects committee will manage adverse reactions at the time of the adverse reaction.

   Time frame: 6 weeks, 3+6+12 months

Individual participant data

Plan to share: No