Assessment of Fixation Strategies for Severe Open Tibia Fractures (FIXIT)
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|ClinicalTrials.gov Identifier: NCT01494519|
Recruitment Status : Recruiting
First Posted : December 19, 2011
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Severe Open Fractures of the Tibia (Shin) Bone||Procedure: Surgery with an external ring fixator Procedure: Definitive fixation with a locked IM nail or plate||Phase 3|
Severe open fractures of the tibia (shin) bone are difficult to treat and are associated with high rates of infection and other complications. There is controversy regarding the best treatment, particularly in fractures with large wounds from trauma. The two current standard treatment options are to place an internal fixation device (a nail or plates with screws) or to use a device with pins that stick out of the skin and attach to rings outside the body (modern ring external fixator). It is unknown which of these standard of care treatment options will result in lower complication rates and better function of the leg.
Our goal is to perform a multi-center randomized controlled trial of the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures. Patients who refuse randomization have the option of participating in a prospective observational study and the treatment is decided by the surgeon and patient.
Primary Aim: To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating "severe" open tibia shaft or metaphyseal fractures with or without a bone defect of any size.
Primary Hypothesis: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the rate of re-hospitalization for major limb complications will be lower for patients treated with ring fixators than those treated with standard internal fixation.
Secondary Hypotheses: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the overall rate of infections will be lower for patients treated with ring fixators than those treated with standard internal fixation. Measures of fracture healing, limb function, and patient reported outcomes (including pain) will be as good or better among patients treated with ring fixators than those treated with standard internal fixation.
Secondary Aim #1: To determine the percentage of Gustilo IIIB open tibia shaft fractures that can be treated successfully (i.e. without amputation) without a soft tissue flap secondary to the use of ring external fixators.
Secondary Aim #2: To determine the two-year treatment costs associated with fixation of "severe" open tibia shaft or metaphyseal fractures (with or without a bone defect of any size) using modern ring external fixators versus standard internal fixation techniques.
Secondary Aim #3: To determine patient reported levels of satisfaction with the fixation method and overall treatment and to compare satisfaction between the two treatment groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||624 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Treament Arm 1
Definitive fixation with an external ring fixator.
Procedure: Surgery with an external ring fixator
Modern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed.
Active Comparator: Treatment arm 2
Definitive fixation with a locked IM nail or plate
Procedure: Definitive fixation with a locked IM nail or plate
Eligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique.
Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
- Re-hospitalization for Complication. [ Time Frame: 2 years ]A hospital re-admission for a complication is defined as any re-admission to the hospital secondary to the treatment of the open tibia fracture for a defined set of complications. The list of complications includes: amputation (at any level), infection (defined using CDC criteria), flap failure, non-union, mal-union, loss of reduction, or hardware failure.
- Infection. [ Time Frame: 2 years ]Infection is defined as either deep or superficial. The presence of tibia infection will be defined by the criteria of CDC. Deep infections are further defined as those that require operative treatment. Superficial infections are defined as those that are treated only with local antibiotics and wound care, and no operative treatment for the infection.
- Fracture Healing. [ Time Frame: 2 years ]Fractures will be evaluated with standard 2 view radiographs of the tibia as is currently performed in standard practice at every clinic visit after the 2 week follow-up. Fracture healing is measured by the treating surgeon using standard clinical criteria.
- Limb Function. [ Time Frame: 2 years ]Limb function will be measured using standard clinical assessments to include weight bearing and ambulation status, knee and ankle range of motion and self selected walking speed.
- Patient Reported Outcome and Quality of Life. [ Time Frame: 2 years ]Outcomes from the patients' perspective will be assessed using standardized questionnaires including the VR-12, the SMFA, and the Paffenbarger activity scale. Depression will be assessed using the PHQ. Post traumatic stress will be measured using the PCL-S.
- Pain [ Time Frame: 2 years ]Pain will be measured using the visual analogue scale (VAS), the brief pain inventory (BPI) and documentation of use of pain medications.
- Satisfaction with treatment [ Time Frame: 2 years ]Patient satisfaction with treatment will be measured using the Short Form Patient Satisfaction Questionnaire (PSQ-18).
- Health Care Costs [ Time Frame: 2 years ]Costs for the initial hospitalization and subsequent care will be estimated using electronic billing records and self reported health service utilization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494519
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|Study Director:||Lisa Reider, MHS, PhD||Major Extremity Trauma Research Consortium|