An interventional study of Intramedullary nailing with standard SIGN nail and External Fixation with uniplanar Dispofix external fixator in Tibial Fractures, Open Fracture of Tibia and Trauma, sponsored by University of California, San Francisco. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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The investigators propose to undertake a randomized, controlled trial which will generate Level 1 evidence concerning optimal fixation methods for the treatment of severe open tibia fractures in Dar es Salaam, Tanzania. The investigators hope to determine the optimal management of severe open tibial fractures in Sub-Saharan Africa in order to reduce long-term disability, limit the economic impact of injury, and avoid resource costs of reoperation. The investigators plan to compare the all-cause reoperation rate for AO/Orthopaedic Trauma Association (OTA) Type 42 open tibial shaft fractures treated with initial intramedullary nailing versus external fixation at Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, to compare rates of secondary clinical endpoints including postoperative superficial and deep infection, clinical union, radiographic union, malunion, and health-related quality of life with minimum one year follow-up, and identify prognostic factors related to the patient, injury, or management protocol that impact the reoperation rate, return to work, and health-related quality of life.
The investigators conducted a prospective randomised controlled trial at a tertiary referral hospital in Dar es Salaam, Tanzania from December 17th, 2015 to March 25th, 2017. All open tibia fractures arriving at the hospital emergency room during the enrollment period were screened for inclusion in the study. Inclusion and exclusion criteria are noted later in this submission.All patients who were eligible after clinical screening were offered enrollment in the study and subsequently completed written informed consent in either English or Swahili depending on the patient's preference. The investigation was approved by ethical review boards at the University of California San Francisco (UCSF) and the Tanzanian National Institute for Medical Research (NIMR).
All enrolled participants were taken to the operating room for initial irrigation and debridement using a standardized protocol aiming for debridement within 24 hours of hospital admission. Preoperative ceftriaxone was given as soon as possible after presentation to the emergency department. Following debridement, the primary surgeon determined if the wound was amenable to immediate or delayed primary closure. If amenable to primary closure, the patient was randomized by a site research coordinator to one of two treatments (Intramedullary nailing (IMN) or external fixation (EF))using a centralized web-based electronic randomization tool, Research Electronic Data Capture (REDCap). The study computer analyst developed the REDCap randomization module with input from senior authors. The REDCap randomization module incorporated block randomization to maintain equal patient distribution between each treatment group and to ensure allocation concealment.
Data from a pilot study at the site of our investigation informed sample size calculations, which showed reoperation rates of external fixation and intramedullary nailing of 38% versus 3.8%. However, with longer follow-up and more stringent criteria for a primary event, The investigators used a more conservative effect size of 20% compared to 5%. Using a power of 80% and alpha of 0.05, The investigators calculated the study would require 88 patients in each treatment group (176 total). Accounting for 20% loss to follow up, The investigators estimated a total sample size requirement of 240 patients (120 per group).
Data monitoring was completed by the adjudication committee at 6 month intervals throughout the study duration and prior to final analysis in December, 2018.
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's enrollment of 240 is above the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
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Exclusion Criteria:
Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures via Intramedullary nailing with standard SIGN nail.
Procedure: Intramedullary nailing with standard SIGN nail
Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures External Fixation with uniplanar Dispofix external fixator.
Procedure: External Fixation with uniplanar Dispofix external fixator
Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the standard SIGN nail (SIGN Fracture Care International, Richland, WA). The number of interlocking screws is at the discretion of the treating surgeon, who also has the option to use an external fixator for damage control, and later conversion to IMN when clinically appropriate. The experimental group procedure is less common in the study setting, and thus, viewed as the experimental group.
Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the uniplanar Dispofix external fixator with two Shanz screws placed proximally and two Schanz screws placed distally to fracture site with a single stainless steel bar.The active comparator group procedure is more common in the study setting, and thus, viewed as the comparator group.
Rate of composite, all-cause reoperation
The use of composite outcomes has been validated in a wide range of clinical trials. Primary events included in the composite outcome include: infection or hematoma, bone grafting, implant conversion or exchange \>6 weeks after index procedure, implant removal, dynamization of intramedullary nail, osteotomy, amputation.
Time frame: One year of definitive skeletal stabilization
Rate of superficial infection
As defined by center for disease control (CDC) surveillance definitions, to include pin tract infections and cellulitis which resolves with use of antibiotics and local wound care.
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Rate of deep infection
As defined by CDC surveillance definitions, to include deep abscess or osteomyelitis.
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Number of participants with clinical nonunion
Union of fracture healing will be assessed by absence of movement at fracture site and time to painless weight bearing. Non-union will be defined as fracture failure to heal beyond six months from date of injury.
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with radiographic nonunion
Radiographic union will be assessed using rate of callous formation and visibility of fracture line as measured by the Radiographic union score for tibia (RUST) score
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with malunion
Post-operative malalignment will be defined as leg length discrepancy (\>1 cm shortening), angular malalignment (\> 5 degrees sagittal or coronal angulation referenced contralateral leg radiographs, if non-injured), or malrotation (\>10 degrees, determined by Foot-Thigh Angle).
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with implant failure
Implant failure will be defined as breakage or loosening of any implant component at bone-implant interface which necessitates re-operation.
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Health-related quality of life
Health related quality of life measured by Euro Quality of Life-5 Dimension (EuroQoL-5D, EQ5D) Index. Contains 5 domains: Mobility, Self-Care, Usual activities, Pain/discomfort, Anxiety/depression Each domain contains 3 levels of health state pertaining to that level. Index score is calculated via weighted scores across each domain. Measured from 0 to 1 where 0 is equivalent to death and 1 is equivalent to perfect state of health.
Time frame: Assessed at 2, 6, 12, 26, and 52 week time point.
Visual analogue pain score
Visual analogue pain score represents a patient's current level of pain scored from 1-10 where 1 = no/minimal pain to 10 = worst possible pain.
Time frame: Assessed at 2, 6, 12, 26, and 52 week time point.
Participant knee range of motion
Includes: * Maximum knee extension/flexion as measured with a goniometer * Values are recorded in degrees from neutral/hyperextension to ≥ 30 by intervals of 5 degrees for maximum knee extension * Values are recorded in degrees from ≤30 degrees to ≥140 degrees by intervals of 10 degrees for maximum knee flexion
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Participant ankle range of motion
Includes: * Maximum ankle dorsiflexion/plantarflexion as measured with a goniometer * Values are recorded in degrees from -15 degrees to \>25 degrees by intervals of 5 degrees for maximum ankle dorsiflexion * Values are recorded in degrees from \<10 degrees to \>50 degrees by intervals of 10 degrees for maximum ankle plantarflexion
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Participant ability to perform Squat and Smile test
The Squat and Smile test (S\&S) is a functional assessment of squatting ability used by SIGN Fracture Care International to quickly assess fracture healing. Squat depth is categorized by squat level: unable (1), above knee level (2), at knee level (3) or below knee level (4) -Values are scored from 1 to 4 where 1 is worst and 4 is best. Support component is categorized by: requiring both hands for support with squatting (1), one hand for support with squatting (2), or no hands for support with squatting (3) -Values are scored from 1 to 3 where 1 is worst and 3 is best Smile component is categorized into painful grimace (1), neutral expression (2), and smile (3) where painful grimace is worst and smile is best. -Values are scored from 1 to 3 where 1 is worst and 3 is best Each component is scored and evaluated individually as separate domains. There is no pooling of scores.
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Patient speed in completing walking speed test according to NIH 4 meter walking test
Measures locomotion Participants walk 4 meters at their usual pace and complete one practice and two timed trials. Raw scores are recorded at the time in seconds required to walk four meters on each of the two trials with the better trial used as the final score.
Time frame: Assessed at 6, 12, 26, and 52 week time point.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data for this study including deidentified participant data and a data dictionary will be made available upon request. The study protocol, statistical analysis plan, and informed consent forms will also be made available upon request. These data and documents will be available with publication. Data and document access can be granted through email correspondence with the corresponding author and will require a signed data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available upon publication. There is no expiration period for data availability.
Access criteria: Investigators requesting data access will be required to submit a cover letter and email to the primary study contact outlining their reasons for requesting data access and their plan for use of study data. All decisions to allow access will be determined by study principal investigators.
Ran from Dec 2015 to primary completion in Mar 2017, 15 months.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's 15 months is below that.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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