Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05501496
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-22
First Post:
2022-08-11
Brief Title:
Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
Internal Fixation Versus Casting of Displaced Tibial Shaft Fractures in Children and Dolescents a Study Protocol of a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CINPED
Brief Summary:
Tibial shaft fracture is a common fracture in the pediatric and adolescent population The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment
The investigators will conduct a multicenter randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis
The investigators will conduct a multicenter randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis
Detailed Description:
Introduction
Tibial shaft fracture is a common fracture in the pediatric and adolescent population Displaced tibial shaft fractures have traditionally been treated with closed reduction and cast immobilization Amount of surgically treated fractures have increased notably especially since flexible intramedullary nails have gained increasing popularity The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment
To this date there is no randomized controlled study comparing non-operative and surgical treatment of tibial fracture in children and adolescent The null hypothesis is that intramedullary nailing of displaced tibial shaft fractures in 7-15 year old skeletally immature pediatric and adolescent patients is superior to cast immobilization in maintaining correct alignment during fracture healing and in restoring of normal functions of the injured limb
Methods and analysis
The Investigators will conduct a multicenter randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis A total of 60 patients will be randomly assigned 11 ratio to closed reduction and cast immobilization or internal fixation with flexible intramedullary nails Investigators will follow the patients 10 years and compare results at baseline and each follow up The primary outcome will be radiographic union at good alignment at one year The secondary outcomes include PedsQL Pediatric Quality of Life Inventory number of re-interventions length of hospital stay complications and volume of injured extremity compared with uninjured leg Patients unwilling for randomization will be asked to participate in a paraller prospective cohort The null hypothesis is that intramedullary nailing is non inferior to conservative treatment
Ethics and dissemination
Investigators have received ethical board approval and permission to conduct the study at each study center Informed consent is obtained from one parent and all patients 12 years or above Results will be disseminated in peer-review publications
Study design
This is a pragmatic parallel group 11 multi-center randomized controlled non-inferiority trial The study is based on a prospective inception cohort design The study is coordinated by Helsinki University Central Hospital Childrens Hospital unit for pediatric orthopedics Recruitment of patients is done at all five Finnish university hospitals Helsinki Tampere Turku Oulu and Kuopio University Hospitals and three central hospitals Satakunta Lappi and Kanta-Häme in Finland with catchment area of 900 000 million children aged less than 16 years of age The trial is registered at clinicaltrialsgov with trial registration number Any changes in study protocol will be uploaded to the trial registry
Patients recruitment
A specialist of either pediatric surgery pediatric orthopedics or orthopedics will screen all patients for inclusion criteria and eligibility If the criteria are met written consent is obtained from one guardian and patients over 12 years Patients and parents are given a written informed consent regarding the trial The patient version is age adjusted for easier understanding
Eligibility criteria
Investigators will include 6 to 15-year old children with open tibial physis capable of communicating in Finnish or Swedish with displaced tibial shaft fracture AO-pediatric classification 42-D41-52 wo fibular fracture that requires manipulation to restore correct displacement and alignment The criteria of unacceptable alignment and need for manipulation are coronal angulation over 5 degrees sagittal angulation over 10 degrees over 50 cortical overlap and over 1 cm shortening
Investigators will exclude patients with open fracture compartment syndrome neurovascular deficit pathological fracture systemic disease affecting bone structure and quality and associated injuries preventing either casting or intramedullary nailing
Randomization All included patients will receive temporary long leg cast after admission to the hospital Randomization is done while patient is under general anesthesia in the operating theater with the treating surgeon opening the assigned envelop
Assigned allocation is sealed in individual coded envelopes
Preferred treatment cohort
Patients meeting inclusion criteria but unwilling to participate in the RCT are asked to join preferred treatment cohort Usually the unwillingness to participate in the RCT is due to a preference for one of the treatment modalities The patients will receive the usual treatment of their choice after information of both methods is given This cohort will continue through the trial in a prospective parallel observational cohort and follow the same treatment and follow up protocol as the randomized patients Analysis of the outcome will be done separately from the randomized group and the results will be compared with the results of the RCT
Baseline
Fracture displacement is calculated by experienced pediatric radiologist and pediatric orthopedic surgeon unrelated to the trial from the lateral and AP radiographs of the injured leg Date of injury method of injury patients age at the time of injury sex injured side time from injury to intervention length of procedure blood loss in the surgery group surgeons level of training consultant registrar and AO-classification of the fracture are documented
Intervention
Cast group
Fracture is reduced under general anesthesia Long leg circular cast synthetic plaster cast or combination according to surgeons preference is applied from toes to upper thigh After casting the alignment is documented with standard AP and lateral radiographs If adequate alignment cannot be achieved after two attempts of casting patient is transferred to intramedullary nailing group and operative treatment is performed under same anesthesia with same principles as in intramedullary nailing group
Cast immobilization with long cast and partial weight bearing is continued for six weeks or until callus of three cortexes can be seen in radiographs Cast wedging in outpatient clinic is performed during follow up if alignment is lost between 10 to 14 days If alignment cannot be restored by wedging patient is recommended to transfer intramedullary nailing group The criteria for unacceptable alignment are coronal angulation over 5 degrees sagittal angulation over 10 degrees over 50 cortical overlap and over 1 cm shortening
Intramedullary nailing IN group
Patients will have prophylactic antibiotic cefuroxime 15mgkg or clindamycin 2mgkg 30-60 minutes before surgery Two flexible intramedullary nails FIN is used to support reduction If adequate closed reduction to allow nail pass across the fracture site is not achieved in 30 minutes open reduction is applied No cast is applied in IN group With flexible intramedullary nails mobilization of knee and ankle joints is allowed immediately post operatively and partial weight bearing is allowed after six weeks or when callus of three cortexes can be seen
Follow up protocol and data collection
Both groups will participate the same follow-up protocol Patients are examined at the outpatient clinic scheduled at 10-14 days 6 weeks and at 3 12 and 24 months and 10 years Alignment and consolidation is documented during each visit with standard lateral and AP radiographs At 12 months follow up a CT scout is performed to find possible length discrepancy and to compare alignment to uninjured leg At each appointment a specific follow up form is filled and patients and guardians are requested to answer Pediatric Quality of Life Inventory PedsQL1920 and Cosmetic visual analogue scale VAS 0-100 The volume of uninjured and injured leg are determined by measuring circumference of leg at its thickest point
Any adverse effects including wound necrosis infections skin problems related to casting time needed for casting before radiographic and clinical consolidation of fracture nerve or tendon injuries delayed union malunion non-union hardware problems possible need for hardware removal and need for crossover from cast group to IN group will be recorded
Outcome
Primary outcome
Primary outcome is radiographic union in good alignment at one-year follow-up measured in anteroposterior AP and lateral radiographs The criteria for malunion are the same as those for acceptable alignment of the primary tibial fracture Tibial length discrepancy will be measured from CT scout compared with uninjured tibia An X-ray of the affected leg will be taken at each follow up and CT scout at 1 year follow up
Two pediatric orthopedic surgeons and one pediatric radiologist all blinded to clinical data will read radiographs Measurements will be recorded as an average of the three separate measurements performed
Secondary outcomes
Pediatric Quality of Life Inventory PedsQL and visual analogy scale VAS at six weeks one year and two year follow up number of re-interventions during two year follow up length of hospital stay complications and volume of injured extremity compared with uninjured leg
Statistical power calculation and analysis
Analysis will be by intention to treat based on children who will reach two-year follow-up In case of significant cross-over a per protocol analysis will be added A difference of 20 between the rates of malunion was set to represent a clinically significant difference between the two treatment methods With the assumption of satisfactory union rates of 75 in the cast group and 95 in the intramedullary nailing group and type I error of 005 and a type II error of 02 50 patients will be needed in each group The sample size will be increased by 10 to allow for drop-outs
After the final data set is formed from the primary data data set access will be limited to the statistician and the authors of the final publication The codes of the RCT arms will be known only to the research assistants until the blinded data interpretation has taken place
Patient and public involvement
Patients guardians or any third party were not involved in the development of this study design Results of this study will be published only in peer-reviewed journals and no information besides that is given to the patients or guardians
Ethics and dissemination
A joint ethical committee evaluation was obtained approval number Dnro ETMK10518012017 for the study from the Ethical Committee of the Hospital for Southwest Finland The separate permission to conduct the trial will be applied at each study center The study is run by Helsinki University Hospital New Childrens Hospital department of Pediatric Orthopedics and Traumatology All patients 12 years or above and their guardians sign a written Informed consent before randomization
Investigators will obtain all research data during the standard orthopedic care of these children Both participant data forms and electronic databases will be maintained in secure storage at the coordinating center for 10 years after completion of study If at any point an imminent problem in healing is observed warranting a change in the treatment regimen this will be done at the discretion of the treating physician regardless of the initial treatment allocation
The participants will be treated according to our best knowledge during and after the trial The Finnish Patient Insurance Centre will provide compensation for treatment injuries The findings of this study will be disseminated through peer-reviewed publications and conference presentations
Tibial shaft fracture is a common fracture in the pediatric and adolescent population Displaced tibial shaft fractures have traditionally been treated with closed reduction and cast immobilization Amount of surgically treated fractures have increased notably especially since flexible intramedullary nails have gained increasing popularity The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment
To this date there is no randomized controlled study comparing non-operative and surgical treatment of tibial fracture in children and adolescent The null hypothesis is that intramedullary nailing of displaced tibial shaft fractures in 7-15 year old skeletally immature pediatric and adolescent patients is superior to cast immobilization in maintaining correct alignment during fracture healing and in restoring of normal functions of the injured limb
Methods and analysis
The Investigators will conduct a multicenter randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis A total of 60 patients will be randomly assigned 11 ratio to closed reduction and cast immobilization or internal fixation with flexible intramedullary nails Investigators will follow the patients 10 years and compare results at baseline and each follow up The primary outcome will be radiographic union at good alignment at one year The secondary outcomes include PedsQL Pediatric Quality of Life Inventory number of re-interventions length of hospital stay complications and volume of injured extremity compared with uninjured leg Patients unwilling for randomization will be asked to participate in a paraller prospective cohort The null hypothesis is that intramedullary nailing is non inferior to conservative treatment
Ethics and dissemination
Investigators have received ethical board approval and permission to conduct the study at each study center Informed consent is obtained from one parent and all patients 12 years or above Results will be disseminated in peer-review publications
Study design
This is a pragmatic parallel group 11 multi-center randomized controlled non-inferiority trial The study is based on a prospective inception cohort design The study is coordinated by Helsinki University Central Hospital Childrens Hospital unit for pediatric orthopedics Recruitment of patients is done at all five Finnish university hospitals Helsinki Tampere Turku Oulu and Kuopio University Hospitals and three central hospitals Satakunta Lappi and Kanta-Häme in Finland with catchment area of 900 000 million children aged less than 16 years of age The trial is registered at clinicaltrialsgov with trial registration number Any changes in study protocol will be uploaded to the trial registry
Patients recruitment
A specialist of either pediatric surgery pediatric orthopedics or orthopedics will screen all patients for inclusion criteria and eligibility If the criteria are met written consent is obtained from one guardian and patients over 12 years Patients and parents are given a written informed consent regarding the trial The patient version is age adjusted for easier understanding
Eligibility criteria
Investigators will include 6 to 15-year old children with open tibial physis capable of communicating in Finnish or Swedish with displaced tibial shaft fracture AO-pediatric classification 42-D41-52 wo fibular fracture that requires manipulation to restore correct displacement and alignment The criteria of unacceptable alignment and need for manipulation are coronal angulation over 5 degrees sagittal angulation over 10 degrees over 50 cortical overlap and over 1 cm shortening
Investigators will exclude patients with open fracture compartment syndrome neurovascular deficit pathological fracture systemic disease affecting bone structure and quality and associated injuries preventing either casting or intramedullary nailing
Randomization All included patients will receive temporary long leg cast after admission to the hospital Randomization is done while patient is under general anesthesia in the operating theater with the treating surgeon opening the assigned envelop
Assigned allocation is sealed in individual coded envelopes
Preferred treatment cohort
Patients meeting inclusion criteria but unwilling to participate in the RCT are asked to join preferred treatment cohort Usually the unwillingness to participate in the RCT is due to a preference for one of the treatment modalities The patients will receive the usual treatment of their choice after information of both methods is given This cohort will continue through the trial in a prospective parallel observational cohort and follow the same treatment and follow up protocol as the randomized patients Analysis of the outcome will be done separately from the randomized group and the results will be compared with the results of the RCT
Baseline
Fracture displacement is calculated by experienced pediatric radiologist and pediatric orthopedic surgeon unrelated to the trial from the lateral and AP radiographs of the injured leg Date of injury method of injury patients age at the time of injury sex injured side time from injury to intervention length of procedure blood loss in the surgery group surgeons level of training consultant registrar and AO-classification of the fracture are documented
Intervention
Cast group
Fracture is reduced under general anesthesia Long leg circular cast synthetic plaster cast or combination according to surgeons preference is applied from toes to upper thigh After casting the alignment is documented with standard AP and lateral radiographs If adequate alignment cannot be achieved after two attempts of casting patient is transferred to intramedullary nailing group and operative treatment is performed under same anesthesia with same principles as in intramedullary nailing group
Cast immobilization with long cast and partial weight bearing is continued for six weeks or until callus of three cortexes can be seen in radiographs Cast wedging in outpatient clinic is performed during follow up if alignment is lost between 10 to 14 days If alignment cannot be restored by wedging patient is recommended to transfer intramedullary nailing group The criteria for unacceptable alignment are coronal angulation over 5 degrees sagittal angulation over 10 degrees over 50 cortical overlap and over 1 cm shortening
Intramedullary nailing IN group
Patients will have prophylactic antibiotic cefuroxime 15mgkg or clindamycin 2mgkg 30-60 minutes before surgery Two flexible intramedullary nails FIN is used to support reduction If adequate closed reduction to allow nail pass across the fracture site is not achieved in 30 minutes open reduction is applied No cast is applied in IN group With flexible intramedullary nails mobilization of knee and ankle joints is allowed immediately post operatively and partial weight bearing is allowed after six weeks or when callus of three cortexes can be seen
Follow up protocol and data collection
Both groups will participate the same follow-up protocol Patients are examined at the outpatient clinic scheduled at 10-14 days 6 weeks and at 3 12 and 24 months and 10 years Alignment and consolidation is documented during each visit with standard lateral and AP radiographs At 12 months follow up a CT scout is performed to find possible length discrepancy and to compare alignment to uninjured leg At each appointment a specific follow up form is filled and patients and guardians are requested to answer Pediatric Quality of Life Inventory PedsQL1920 and Cosmetic visual analogue scale VAS 0-100 The volume of uninjured and injured leg are determined by measuring circumference of leg at its thickest point
Any adverse effects including wound necrosis infections skin problems related to casting time needed for casting before radiographic and clinical consolidation of fracture nerve or tendon injuries delayed union malunion non-union hardware problems possible need for hardware removal and need for crossover from cast group to IN group will be recorded
Outcome
Primary outcome
Primary outcome is radiographic union in good alignment at one-year follow-up measured in anteroposterior AP and lateral radiographs The criteria for malunion are the same as those for acceptable alignment of the primary tibial fracture Tibial length discrepancy will be measured from CT scout compared with uninjured tibia An X-ray of the affected leg will be taken at each follow up and CT scout at 1 year follow up
Two pediatric orthopedic surgeons and one pediatric radiologist all blinded to clinical data will read radiographs Measurements will be recorded as an average of the three separate measurements performed
Secondary outcomes
Pediatric Quality of Life Inventory PedsQL and visual analogy scale VAS at six weeks one year and two year follow up number of re-interventions during two year follow up length of hospital stay complications and volume of injured extremity compared with uninjured leg
Statistical power calculation and analysis
Analysis will be by intention to treat based on children who will reach two-year follow-up In case of significant cross-over a per protocol analysis will be added A difference of 20 between the rates of malunion was set to represent a clinically significant difference between the two treatment methods With the assumption of satisfactory union rates of 75 in the cast group and 95 in the intramedullary nailing group and type I error of 005 and a type II error of 02 50 patients will be needed in each group The sample size will be increased by 10 to allow for drop-outs
After the final data set is formed from the primary data data set access will be limited to the statistician and the authors of the final publication The codes of the RCT arms will be known only to the research assistants until the blinded data interpretation has taken place
Patient and public involvement
Patients guardians or any third party were not involved in the development of this study design Results of this study will be published only in peer-reviewed journals and no information besides that is given to the patients or guardians
Ethics and dissemination
A joint ethical committee evaluation was obtained approval number Dnro ETMK10518012017 for the study from the Ethical Committee of the Hospital for Southwest Finland The separate permission to conduct the trial will be applied at each study center The study is run by Helsinki University Hospital New Childrens Hospital department of Pediatric Orthopedics and Traumatology All patients 12 years or above and their guardians sign a written Informed consent before randomization
Investigators will obtain all research data during the standard orthopedic care of these children Both participant data forms and electronic databases will be maintained in secure storage at the coordinating center for 10 years after completion of study If at any point an imminent problem in healing is observed warranting a change in the treatment regimen this will be done at the discretion of the treating physician regardless of the initial treatment allocation
The participants will be treated according to our best knowledge during and after the trial The Finnish Patient Insurance Centre will provide compensation for treatment injuries The findings of this study will be disseminated through peer-reviewed publications and conference presentations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None