Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04385745 |
| Other study ID # |
University of Oulu |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2019 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Oulu University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
