Tibial FracturesNCT03861624
Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania
A study testing Intramedullary nailing with standard SIGN nail and External Fixation with uniplanar Dispofix external fixator in people with Tibial Fractures and Open Fracture of Tibia, run by University of California, San Francisco.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures, Open Fracture of Tibia, Trauma
- What is being tested?
- Intramedullary nailing with standard SIGN nail and External Fixation with uniplanar Dispofix external fixator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2015to 25 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletal maturity
- AO/OTA 42 open tibia fractures
- Wound primarily closeable (no flap or delay in closure due to contamination needed)
- Palpable pedal pulses (no vascular injury sustained)
- Presentation within 24 hours from injury
Who cannot join
- Current injury is a pathologic fracture
- Sustained bilateral tibia fracture
- Sustained comminuted femur fracture
- Sustained severe Traumatic Brain Injury (GCS<12) ***
- Sustained severe spinal cord injury (lower extremity paresis/paralysis)
- Sustained severe burns (>10% total body surface area (TBSA) or >5% TBSA with full thickness or circumferential injury)
Show all 9Show fewer
- Prior ipsilateral leg injury requiring surgery
- Prior or current lower limb deformity or abnormality
- Unable to complete follow-up visits
About this study
Official title: Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibia Fractures in Tanzania - Results of a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Tibial Fractures, Open Fracture of Tibia, Trauma
- Being tested
- Intramedullary nailing with standard SIGN nail, External Fixation with uniplanar Dispofix external fixator
- Keywords
- Tibia, Intramedullary nailing, External fixation, Trauma
- Medical subject headings
- Tibial Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailing with standard SIGN nailProcedure or surgery
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.
External Fixation with uniplanar Dispofix external fixatorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nailing | Experimental | Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures via Intramedullary nailing with standard SIGN nail. Receives: Procedure: Intramedullary nailing with standard SIGN nail |
| External Fixation | Active comparator | Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures External Fixation with uniplanar Dispofix external fixator. Receives: Procedure: External Fixation with uniplanar Dispofix external fixator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year of definitive skeletal stabilization
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Assessed at 6, 12, 26, and 52 week time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start17 Dec 2015
- Primary completion25 Mar 2017
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Wyss Foundation, Inc, Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Saam Morshed, MD, MPH, Study chair, University of California, San FranciscoDavid Shearer, MD, MPH, Principal investigator, University of California, San FranciscoBilly Haonga, MD, Principal investigator, Muhimbili Orthopaedic InstituteEdmund Eliezer, MD, Principal investigator, Muhimbili Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861624
- Sponsor's protocol ID
- 14-14792
- Status last verified
- Jul 2022
- First submitted
- 25 Feb 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Chandran A, Hyder AA, Peek-Asa C. The global burden of unintentional injuries and an agenda for progress. Epidemiol Rev. 2010;32(1):110-20. doi: 10.1093/epirev/mxq009. Epub 2010 Jun 22.
PubMed 20570956Patton GC, Coffey C, Sawyer SM, Viner RM, Haller DM, Bose K, Vos T, Ferguson J, Mathers CD. Global patterns of mortality in young people: a systematic analysis of population health data. Lancet. 2009 Sep 12;374(9693):881-92. doi: 10.1016/S0140-6736(09)60741-8.
PubMed 19748397Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5.
PubMed 18679760Beveridge M, Howard A. The burden of orthopaedic disease in developing countries. J Bone Joint Surg Am. 2004 Aug;86(8):1819-22. doi: 10.2106/00004623-200408000-00029.
PubMed 15292432WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
PubMed 14679827Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future concerns. J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96. doi: 10.5435/00124635-200109000-00002.
PubMed 11575908Museru LM, Mcharo CN. The dilemma of fracture treatment in developing countries. Int Orthop. 2002;26(6):324-7. doi: 10.1007/s00264-002-0408-7. Epub 2002 Oct 17. No abstract available.
PubMed 12466862Zirkle LG Jr. Injuries in developing countries--how can we help? The role of orthopaedic surgeons. Clin Orthop Relat Res. 2008 Oct;466(10):2443-50. doi: 10.1007/s11999-008-0387-0. Epub 2008 Aug 7.
PubMed 18685912Shah RK, Moehring HD, Singh RP, Dhakal A. Surgical Implant Generation Network (SIGN) intramedullary nailing of open fractures of the tibia. Int Orthop. 2004 Jun;28(3):163-6. doi: 10.1007/s00264-003-0535-9. Epub 2004 Jan 9.
PubMed 14714143Shearer D, Cunningham, B., Zirkle, L. Population Characteristics and Clinical Outcomes from the SIGN Online Surgical Database. Techniques in Orthopaedics. 2009;24(4):273-276.
Ikpeme I, Ngim N, Udosen A, Onuba O, Enembe O, Bello S. External jig-aided intramedullary interlocking nailing of diaphyseal fractures: experience from a tropical developing centre. Int Orthop. 2011 Jan;35(1):107-11. doi: 10.1007/s00264-009-0949-0. Epub 2010 Feb 11.
PubMed 20148329Ogunlusi JD, St Rose RS, Davids T. Interlocking nailing without imaging: the challenges of locating distal slots and how to overcome them in SIGN intramedullary nailing. Int Orthop. 2010 Aug;34(6):891-5. doi: 10.1007/s00264-009-0882-2. Epub 2009 Oct 8.
PubMed 19813011Naeem-Ur-Razaq M, Qasim M, Khan MA, Sahibzada AS, Sultan S. Management outcome of closed femoral shaft fractures by open Surgical Implant Generation Network (SIGN) interlocking nails. J Ayub Med Coll Abbottabad. 2009 Jan-Mar;21(1):21-4.
PubMed 20364733Ikem IC, Ogunlusi JD, Ine HR. Achieving interlocking nails without using an image intensifier. Int Orthop. 2007 Aug;31(4):487-90. doi: 10.1007/s00264-006-0219-3. Epub 2006 Oct 13.
PubMed 17039384Sekimpi P, Okike K, Zirkle L, Jawa A. Femoral fracture fixation in developing countries: an evaluation of the Surgical Implant Generation Network (SIGN) intramedullary nail. J Bone Joint Surg Am. 2011 Oct 5;93(19):1811-8. doi: 10.2106/JBJS.J.01322.
PubMed 22005867
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibia Fractures in Tanzania - Results of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03861624
- Acronym / sponsor ID
- 14-14792
- Conditions
- Tibial Fractures, Open Fracture of Tibia, Trauma
- Keywords
- Tibia, Intramedullary nailing, External fixation, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Wyss Foundation, Inc, Doris Duke Charitable Foundation
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nailing | Experimental | Procedure: Intramedullary nailing with standard SIGN nailPatients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures via Intramedullary nailing with standard SIGN nail. |
| External Fixation | Active comparator | Procedure: External Fixation with uniplanar Dispofix external fixatorPatients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures External Fixation with uniplanar Dispofix external fixator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skeletal maturity
- AO/OTA 42 open tibia fractures
- Wound primarily closeable (no flap or delay in closure due to contamination needed)
- Palpable pedal pulses (no vascular injury sustained)
- Presentation within 24 hours from injury
Key exclusion criteria (9 listed)
- Current injury is a pathologic fracture
- Sustained bilateral tibia fracture
- Sustained comminuted femur fracture
- Sustained severe Traumatic Brain Injury (GCS<12) ***
- Sustained severe spinal cord injury (lower extremity paresis/paralysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary nailing with standard SIGN nailPatients 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. | Procedure or surgery | Intramedullary nailing |
| External Fixation with uniplanar Dispofix external fixatorPatients 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. | Procedure or surgery | External Fixation |
Primary outcome
Rate of composite, all-cause reoperation
Time frame: One year of definitive skeletal stabilization
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.
12 secondary outcomes
Rate of superficial infection
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Rate of deep infection
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Number of participants with clinical nonunion
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with radiographic nonunion
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with malunion
Time frame: Assessed at clinical follow-up appointments at 6, 12, 26, and 52 weeks
Number of participants with implant failure
Time frame: Assessed at clinical follow-up appointments at 2, 6, 12, 26, and 52 weeks
Health-related quality of life
Time frame: Assessed at 2, 6, 12, 26, and 52 week time point.
Visual analogue pain score
Time frame: Assessed at 2, 6, 12, 26, and 52 week time point.
Participant knee range of motion
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Participant ankle range of motion
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Participant ability to perform Squat and Smile test
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
Time frame: Assessed at 6, 12, 26, and 52 week time point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 20570956Chandran A, Hyder AA, Peek-Asa C. The global burden of unintentional injuries and an agenda for progress. Epidemiol Rev. 2010;32(1):110-20. doi: 10.1093/epirev/mxq009. Epub 2010 Jun 22.
- Background: PubMed 19748397Patton GC, Coffey C, Sawyer SM, Viner RM, Haller DM, Bose K, Vos T, Ferguson J, Mathers CD. Global patterns of mortality in young people: a systematic analysis of population health data. Lancet. 2009 Sep 12;374(9693):881-92. doi: 10.1016/S0140-6736(09)60741-8.
- Background: PubMed 18679760Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5.
- Background: PubMed 15292432Beveridge M, Howard A. The burden of orthopaedic disease in developing countries. J Bone Joint Surg Am. 2004 Aug;86(8):1819-22. doi: 10.2106/00004623-200408000-00029.
- Background: PubMed 14679827WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
- Background: PubMed 11575908Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future concerns. J Am Acad Orthop Surg. 2001 Sep-Oct;9(5):289-96. doi: 10.5435/00124635-200109000-00002.
- Background: PubMed 12466862Museru LM, Mcharo CN. The dilemma of fracture treatment in developing countries. Int Orthop. 2002;26(6):324-7. doi: 10.1007/s00264-002-0408-7. Epub 2002 Oct 17. No abstract available.
- Background: PubMed 18685912Zirkle LG Jr. Injuries in developing countries--how can we help? The role of orthopaedic surgeons. Clin Orthop Relat Res. 2008 Oct;466(10):2443-50. doi: 10.1007/s11999-008-0387-0. Epub 2008 Aug 7.
- Background: PubMed 14714143Shah RK, Moehring HD, Singh RP, Dhakal A. Surgical Implant Generation Network (SIGN) intramedullary nailing of open fractures of the tibia. Int Orthop. 2004 Jun;28(3):163-6. doi: 10.1007/s00264-003-0535-9. Epub 2004 Jan 9.
- BackgroundShearer D, Cunningham, B., Zirkle, L. Population Characteristics and Clinical Outcomes from the SIGN Online Surgical Database. Techniques in Orthopaedics. 2009;24(4):273-276.
- Background: PubMed 20148329Ikpeme I, Ngim N, Udosen A, Onuba O, Enembe O, Bello S. External jig-aided intramedullary interlocking nailing of diaphyseal fractures: experience from a tropical developing centre. Int Orthop. 2011 Jan;35(1):107-11. doi: 10.1007/s00264-009-0949-0. Epub 2010 Feb 11.
- Background: PubMed 19813011Ogunlusi JD, St Rose RS, Davids T. Interlocking nailing without imaging: the challenges of locating distal slots and how to overcome them in SIGN intramedullary nailing. Int Orthop. 2010 Aug;34(6):891-5. doi: 10.1007/s00264-009-0882-2. Epub 2009 Oct 8.
- Individual participant dataSharing planned: 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.
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Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saam Morshed, MD, MPH study chair
University of California, San Francisco
David Shearer, MD, MPH principal investigator
University of California, San Francisco
Billy Haonga, MD principal investigator
Muhimbili Orthopaedic Institute
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nailing with standard SIGN nail and External Fixation with uniplanar Dispofix external fixator in people with Tibial Fractures and Open Fracture of Tibia, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite, all-cause reoperation (time frame: One year of definitive skeletal stabilization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03861624, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.