Treatment of Children's Forearm Shaft Fractures With Biodegradable Intramedullary Nailing, Compared With Elastic Stable Intramedullary Nailing
Condition: Fractures, Bone; Injury Arm
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      The study purpose is to investigate long-term biodegradation process of the
      polylactide-co-glycolide (PLGA) intramedullary nails, used in treating the forearm shaft
      fractures in children. The primary objective of the study is to determine the stage of
      biodegradation of the polylactide-co-glycolide intramedullary nails, compared with the time
      since operation.

      Biodegradation is to be evaluated by using Magnetic Resonance Imaging (MRI). Potential
      adverse events, being related to the biodegradation process of the implant, will be
      recognized: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation and
      other soft-tissue reactions in the surroundings of the former fracture will be evaluated.

      Radiographic recovery at least 4 years after the implant operation is secondary aims of the
      study. Radiographic investigation (plain radiographs in lateral and anterior-posterior views)
      are taken to evaluate the signs of bone healing after the long-bone diaphysis fracture,
      including the resolution of the previous callus formation, tubularization of the long-bones
      around the previous fracture area and remodeling of the angular and rotational alignment.

      Clinical recovery in the long-term (at least 4 years) is another secondary aim of the study.

      Prospective observational study will be performed. The study population comprises all the
      cases who were participating in the previous RCT ("BIOABSORBABLE INTRAMEDULLARY NAIL FIXATION
      OF FOREARM FRACTURES IN CHILDREN") and were therefore treated by means of biodegradable
      intramedullary nailing in years 2010 to 2015 (N=16).

      All these patients will be invited and at least 4-year follow-up visit is performed at
      out-hospital clinics in the study institutions and radiographs and MRI will be taken. Flynn's
      criteria, MAYO elbow performance score and mini-DASH will be used. Health-related quality of
      life is to be analysed by using Pediatric Quality of Life Inventory (PedsQL). Visual analogue
      scale will be used for determining residual pain. A comprehensive analysis concerning the
      radiographic bone healing, according to Lane-Sandhu -scoring is determined and biodegradation
      of the implants, including the tricalciumphosphate tip will be evaluated by using MRI.

      Number of Patients: N=15

      Diagnosis and Main Criteria for Inclusion and Exclusion:

      The study cases of the previous original research, described above, will be used to comprise
      the study population of the current project. The subject and/or guardian are invited to the
      study by a postal letter and by a call in case of no show. A signed and dated informed
      consent is required upon the participation.

      Costs: The patients are to be investigated for long-term recovery according to the normal
      treatment protocol and no extra costs are caused for the patients or the institutes. The
      reason for further long-term follow-up and further imaging at four years' mark is that the
      implants were still visible in the patients at their last follow-up visit in two years' mark,
      in the previous research that has been terminated.

      Safety and ethical consideration:

      There are no health-related issues in clinical investigation and MRI of the patients. The
      plain radiographs of the upper extremities predispose the participants to radiation, with
      equivalence to 1-2 days of background radiation (www.stuk.fi, radiation doses). However,
      radiographs are not taken of gravidae females.

      The study causes burden for the participants due to follow-up visit. In case of children and
      adolescents, the parents' presence is appreciated. However, long-term follow-up is justified
      because of the history of several injury and invasive surgical treatment performed and in
      order to certain the final degradation of the used implant.

      Statistical Methods:

      The radiographic and clinical findings will be reported in descriptive means. The mean, range
      and standard deviation (SD) will be reported for the continous variables. The issues in the
      short-term recovery and the potential association between the short-term findings and
      long-term results are analysed by using the SND test for independent variables. Further, the
      association of the clinical findings and subjective symptoms with the degradation stage of
      the implants will be investigated. Other appropriate statistical methods may also be used.
      All P-values are two-tailed and the level of significance is set as <0.05.
    

Detailed description: 
      This is a prospective observational clinical study in two centers in Finland. The study
      cannot be executed in a blinded fashion, because all patients treated by the study method
      will be invited.

      The study purpose is to investigate long-term biodegradation process of the
      polylactide-co-glycolide intramedullary nails, used in treating the forearm shaft fractures
      in children. It is aimed to determine the stage of biodegradation of the
      polylactide-co-glycolide intramedullary nails, compared with the time since operation and the
      potential complications and/or radiographic and clinical recovery at least 4 years after the
      implant implementation.

      Close clinical recovery is another objective of the study.

      Potential adverse events, being related to the biodegradation process of the implant, are to
      be evaluated: fluid accumulation, sinus formation, osteolysis, swelling, cyst formation.
      Further, the soft-tissue reaction in the surroundings of the former fracture will be
      evaluated.

      Radiographic recovery will be be evaluated in means of plain radiograph investigation (plain
      radiographs in lateral and anterior-posterior views). The signs of bone healing after the
      long-bone diaphysis fracture, including the resolution of the previous callus formation,
      tubularization of the long-bones around the previous fracture area, remodeling of the angular
      and rotational alignment will be analyzed.
    

Intervention name(s): Biodegradable Intramedullary Nailing (BIN)
Intervention type(s): Procedure
Intervention description(s): Unstable forearm shaft fractures are treated by the study method (BIN) or the control method (ESIN).
Other intervention name(s): Elastic Stable Intramedullary Nailing (ESIN)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled clinical trial.
Masking: None (Open Label)
Primary purpose: Treatment