Tibial Fractures
Conditions
Brief summary
This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury. Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith & Nephew, England) or a reamed intramedullar nail (according to local choice) with locking screws. Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36) after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications, healing, malunion, and resource use.
Detailed description
Fractures of the lower leg (fractures of the tibia shaft with or without concurrent fracture of the fibula) are a common injury. According to our fracture register 95 patients with closed tibia fractures were operated the last 3 years at our department. Fractures with moderate or no displacement can be successfully treated with a cast and subsequent Sarmiento brace. Displaced fractures are commonly treated with an intramedullary nail. Intramedullary nailing yields a high rate of union. More than 50 % of operated patients do, however, develop chronic anterior knee pain and one third of the patients have pain at rest. This contributes a big problem for many patients both at spare time and at work. Another problem is significant rates of malunion. The use of ring fixators utilizing rings and 1,8 mm. wires was introduced by Gavril Ilizarov more than 50 years ago, and the technique has been further developed through the introduction of six adjustable struts (Taylor Spatial Frame). This hexapod circular frame allows accurate reduction as well as a high stability. The ring fixator is less invasive and allows early weight bearing, but may be cumbersome to the patient. There is also concern about pin-tract infection, osteomyelitis and joint contracture. Only one prior study has compared ring fixator (Ilizarov) and intramedullar nail in closed tibia fractures. The results showed significant less anterior knee pain in the patients operated with ring fixator, but the study design did not allow clear conclusion.
Interventions
DEVICETaylor Spatial Frame
Circular external fixator
DEVICEIntramedullary nail
Antegrade intramedullary nail
Sponsors
Sahlgrenska University Hospital
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The researcher doing the statistical analyses will be masked for treatment Group (i.e. Group 1 or 2) in a databse blinded for treatment grioups and without variables indirectly revealing treatmnet arm. These will be analyzed later.
Intervention model description
Prospective randomized two-group clinical trial with block randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Closed tibia shaft fractures suited for both study treatments. * A patient who is informed of the purpose of the investigation and who has given informed consent and willingness to accept randomisation either to Taylor Spatial Frame or intramedullary nailing. * Willingness and ability to comply with all investigation procedures * Age between 18 to 70 years * Skeletally mature * Previous unaided walking
Exclusion criteria
* Participation in other clinical investigations that will interfere with this study * Mental illness or other conditions that preclude ring fixator in the judgment of the investigator * Any other concurrent condition(s) that, in the judgment of the investigator, would prohibit the patient from participation in the study * No other injury or previous disease that would be likely to seriously influence the long term outcome (this will exclude e.g. osteomyelitis, vascular or neurological disorder of the lower extremities, rheumatoid artist, malignancy that could influence on bone healing) * Compartment syndrome before randomisation * Pathologic fracture * Ongoing or previous use the last year of drugs that can be bone anabolic (e.g. anabolic steroids, growth hormone, parathyroid hormone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Component summary of RAND SF 36 (Short Form 36) | 24 months | Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bodily pain, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| General health perceptions, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Vitality Subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Physical role functioning, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Emotional role functioning, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Social role functioning, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Mental health, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Physical Component summary of RAND (SF) 36 | 6, 12 months | Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better. |
| Pain around the knee | 6, 12, 24 months | VAS scale 0-10 |
| Pain around the fracture site | 6, 12, 24 months | VAS scale 0-10 |
| Physical functioning, subscore of RAND (SF) 36 | 6, 12, 24 months | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
| Complications major (composite) | 24 months | Compartment syndrome, sequela compartment syndrome (e.g. short foot, clawing, neurological disorder), infection that needs operation, any unexpected reoperation (except removal of single pins or screws) |
| Complications minor (composite) | 24 months | pin tract infection that needs antibiotics, wound complication that don't need reoperation, unexpected minor reoperations (i.e. removal of single pins or screws) |
| Reoperations minor (composite) | 6, 12, 24 months | Minor reoperation (e.g. remove/exchange pins, remove/exchange screws) |
| Reoperations major (composite) | 6, 12, 24 months | Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union) |
| Time to union (composite) | 6, 12, 24 months | Time to fracture union in days. We require both radiographical union defined by callus bridging 3 of 4 cortices AND clinical union defined by full, pain free and unaided weight bearing. |
| Resource use; Away from work | 24 months | Number of days away from work for employed patients |
| Resource use; Emergency contacts | 24 months | Number of unscheduled contacts with hospital regarding tibia fracture |
| Resource use; Length of stay | 24 months | Hospital stay in days for index stay |
| Resource use; Operation time | 24 months | Surgery time in minutes for index surgery |
| Pain around the ankle | 6, 12, 24 months | VAS scale 0-10 |
Countries
Norway
Outcome results
None listed