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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circular frame external fixator | Experimental | A Taylor Spatial Frame should consist of 2 rings with 4 half pins/K-wire attached to each ring. If possible 3, not hydroxyapatite-coated, half pins and one K-wire should be attached to each ring. The half pins/K-wire should be spread in distance and direction for optimum stability. |
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| Intramedullary nail | Active Comparator | Nailing technique according to Karladani and Styf published technique (ref: Karladani AH, Styf J. Percutaneous intramedullary nailing of tibial shaft fratures: a new approach for prevention of anterior knee pain. Injury, Int. J. Care Injury 32 (2001) 736-39) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taylor Spatial Frame | Device | Circular external fixator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Component summary of RAND SF 36 (Short Form 36) | Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitality Subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Physical functioning, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan E Madsen, PhD | Professor, head of research group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Center, Ulleval University Hospital | Oslo | 0408 | Norway |
Depending on demand. No plan as of yet.
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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Prospective randomized two-group clinical trial with block randomization.
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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.
| Intramedullary nail | Device | Antegrade intramedullary nail |
|
| 6, 12, 24 months |
| Bodily pain, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| General health perceptions, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Physical role functioning, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Emotional role functioning, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Social role functioning, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Mental health, subscore of RAND (SF) 36 | Generic Health Related Quality of Life. Range 0 (worst) to 100 (best). | 6, 12, 24 months |
| Physical Component summary of RAND (SF) 36 | Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better. | 6, 12 months |
| Pain around the knee | VAS scale 0-10 | 6, 12, 24 months |
| Pain around the fracture site | VAS scale 0-10 | 6, 12, 24 months |
| Pain around the ankle | VAS scale 0-10 | 6, 12, 24 months |
| Complications major (composite) | 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) | 24 months |
| Complications minor (composite) | pin tract infection that needs antibiotics, wound complication that don't need reoperation, unexpected minor reoperations (i.e. removal of single pins or screws) | 24 months |
| Reoperations minor (composite) | Minor reoperation (e.g. remove/exchange pins, remove/exchange screws) | 6, 12, 24 months |
| Reoperations major (composite) | Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union) | 6, 12, 24 months |
| Time to union (composite) | 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. | 6, 12, 24 months |
| Resource use; Away from work | Number of days away from work for employed patients | 24 months |
| Resource use; Emergency contacts | Number of unscheduled contacts with hospital regarding tibia fracture | 24 months |
| Resource use; Length of stay | Hospital stay in days for index stay | 24 months |
| Resource use; Operation time | Surgery time in minutes for index surgery | 24 months |
| D013514 |
| Surgical Procedures, Operative |