Comparative Trial of Operative Treatment of Distal Pediatric Forearm Fractures With Biodegradable Nails and K-wires

Multicenter Prospective Trial for Operative Treatment of Distal Pediatric Forearm Fractures With PLGA-based Biodegradable Material (Activa Im-Nails™) and Conventional Implants (K-wires)

The study is designed as a multicenter trial for the treatment of distal pediatric forearm fractures (=severely displaced distal metaphyseal forearm fractures) with a PLGA-based biodegradable intramedullary implant in children. The primary objective of the trial is to evaluate clinical outcome between Activa IM-Nail™ and K-wire in this indication. The secondary objective is to evaluate potential differences of potential complications in the operative method with either a biodegradable intramedullary PLGA-implant or with conventional K-wires. K-wire osteosynthesis will be made according to the conventional surgical technique by three paediatric trauma centers. Intramedullary PLGA implantation will be made by the Péterfy Hospital. The surgical indication will be the same in all groups, and follow-up will follow standard protocols. In the further clinical course, the patients in the study group treated with PLGA implants spare a subsequent operation for implant removal after 4-8 weeks. The results of different surgeries will be compared based on several criteria.

Study Overview

• Status: Recruiting
• Conditions: Fracture Wrist
• Intervention / Treatment: Procedure: Distal radial metaphyseal fracture fixation with percutaneous K-wires; Procedure: Distal radial and/or ulnar metaphyseal fracture fixation with bidegradable PLGA-based (Activa Im-Nail) implants

Detailed Description

Over the last decade, there has been an increasing demand to overcome the disadvantages associated with conventional implant materials, by developing new, alternative materials and material production approaches for use in trauma care.

In recent years there has been a growing interest in the orthopaedic application of resorbable implants. Their use in children may be particularly beneficial. Poly(L-lactide)-co-glycolide acid (PLGA) is a well-known, reliable biodegradable material that has been used in bone surgery for more than 20 years. Several publications have already reported the successful use of intra-medullar PLGA implants in the treatment of paediatric diaphyseal forearm fractures.

To gather further evidence about the clinical value of the new method with PLGA - based bioresorbable implant in regard to patients benefit, a multicenter prospective trial is needed. This trial will be conducted on the distal forearm, which is one of the most common fracture locations that requires surgical intervention in children. Severely displaced distal paediatric forearm fractures will be addressed.

Distal paediatric forearm injuries

Distal radius fractures are among the most common injuries of childhood. Optimal treatment for distal radius fractures is still controversial. Treatment of severely displaced and shortened fractures usually require general narcosis and closed reduction. Most authors recommend osteosynthesis if the fracture remains unstable after reduction. The gold standard operative method for these fractures is closed reduction, percutaneous pinning with Kirschner-wires.

Kirschner-wire related minor complications are relatively frequent. Migration of the pins, superficial infections, skin irritation are well manageable but significantly impair the child's sense of comfort. Deep infections, tendon or nerve injuries may occur less often. There is a controversy as to whether it is preferable to leave the wires outside the skin. While wires left out of the skin increase the risk of infection, wires buried under the skin can be removed with a second intervention. Removing the implants can also cause complications.

K-wires are not capable of providing sufficient stabilization in this indication, so additional casting treatment is also required. The duration and the type of postoperative immobilization varies greatly according to the practice of the surgeons. There is no evidence about the most optimal immobilization procedure. 4-6 weeks of cast wearing is recommended by most authors. This causes stiffness in the affected joints and delays the recovery of full function. Fractures with intramedullary elastic nails require a reduced time of immobilization because they provide a more stable synthesis, but nails can be removed only under general anaesthesia. The use of bioabsorbable intramedullary nails in distal paediatric forearm fractures may eliminate all of the above-mentioned disadvantages.

The study is designed as a multicenter trial for the treatment of distal pediatric forearm fractures (=severely displaced distal metaphyseal forearm fractures) with a PLGA-based biodegradable intramedullary implant in children. The primary objective of the trial is to evaluate clinical outcome between Activa IM-Nail™ and K-wire in this indication. The secondary objective is to evaluate potential differences of potential complications in the operative method with either a biodegradable intramedullary PLGA-implant or with conventional K-wires. K-wire osteosynthesis will be made according to the conventional surgical technique by two paediatric trauma centers. Intramedullary PLGA implantation will be made by the Péterfy Hospital. The surgical indication will be the same in all groups, and follow-up will follow standard protocols. In the further clinical course, the patients in the study group treated with PLGA implants spare a subsequent operation for implant removal after 4-8 weeks. The results of different surgeries will be compared based on several criteria.

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcell Varga, PhD; Phone Number: 0036709323027; Email: drvmarcell@gmail.com
• Study Contact Backup: Name: Tamás Kassai, MD; Phone Number: 003612997700; Email: kassai.tamas@obsi.hu

Study Locations

• Hungary
  • Diós Árok 1.
    • Budapest, Diós Árok 1., Hungary, 1125
      • Recruiting
      • Szent János Hospital
      • Contact: András Petrovics, MD; Phone Number: 0036309817337; Email: afeso4@gmail.com
      • Contact: Tamás Mona, MD; Phone Number: 0036209965234; Email: monatamas@gmail.com
  • Fiumei Út 17
    • Budapest, Fiumei Út 17, Hungary, 1081
      • Recruiting
      • Péterfy Hospital
      • Contact: Marcell Varga, PhD; Phone Number: 0036709323027; Email: drvmarcell@gmail.com
  • József Attila U 7.
    • Pécs, József Attila U 7., Hungary, 7623
      • Recruiting
      • Medical University of Pécs, Pediatric Surgery
      • Contact: Gergő Józsa, PhD; Phone Number: 0036305142730; Email: dr.jozsa.gergo@gmail.com
  • Üllöi Út 86
    • Budapest, Üllöi Út 86, Hungary, 1089
      • Recruiting
      • Heim Pal Hospital
      • Contact: Rita Varga, MD; Phone Number: 0036303306445; Email: ritusvarga@citromail.hu
      • Contact: Zoltán Ringwald, MD; Phone Number: 0036204032800; Email: ringwaldzoltan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of distal radial or complete forearm fracture Metaphyseal radial/or distal forearm fractures with complete displacement and shortening.

Age between of 3-13 years. Open physeal plates on X-rays. Closed or Grade I. open fractures Ability and willingness to give an informed consent

Exclusion Criteria:

Pathological fractures (e.g. bone cyst) Poly-traumatized patient Inability or unwillingness to give informed consent Closed physeal plates on X-rays. Active skin infection in the surgical area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: K-wire group; Children with closed or grade I. open, severly displaced distal radial and/or complete forearm metaphyseal fractures between the age 3-13.	Procedure: Distal radial metaphyseal fracture fixation with percutaneous K-wires; Pediatric distal metaphyseal fractures which are severly displaced will be operated with percutaneous K-wires..
Active Comparator: Activa-IM Nail group; Children with closed or grade I. open, severly displaced distal radial and/or complete forearm metaphyseal fractures between the age 3-13.	Procedure: Distal radial and/or ulnar metaphyseal fracture fixation with bidegradable PLGA-based (Activa Im-Nail) implants; Pediatric distal metaphyseal radial and /or ulnar fractures which are severly displaced will be operated with percutaneous bidegradable PLGA-based (Activa Im-Nail) implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ correlate to less complications than the conventional K- wiring technique in displaced pediatric distal forearm or radial metaphyseal fractures?	We compare the incidence of minor and major complications of both surgical technique. These are: superficial skin infection, tendon injury, nerve injury, secondary displacement, deep infection, skin irritation.	Six months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ also reduce the postoperative immobilisation time?	Calculation of postoperative immobilisation time in weeks. Calculation and comparison the necessary immobilisation times in both surgical techniques.	Eight weeks after operation
Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ not require a second intervention?	Calculation and comparioson of the number of a second operative intervention in both surgical techniqes.	Six months after operation
Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ also reduce the postoperative outpatient visits?	Calculation and comparison the number of postoperative outpatient visits in both surgical techniques.	1 year after operation
Does the short intramedullary nailing operative method with biodegradable nails and K-wire technique results a full recovery of the functions within six months?	Examination by the range of motion method (ROM) of the wrists of the patients. Full recovery means , that the range of pronation/supination and flexion/extension of the wrist will be the same as the range of the healthy side.The examination is also performed at weeks 4,8,and 24.	Six months after operation
Does the short intramedullary nailing operative method with biodegradable nails shortens the recovery time for the full function compared to the K-wiring method?	Based on the results of ROM -method examinations performed at weeks 4,8 and 24 weeks ,we compare and calculate the difference in the rates of function recovery in both surgical technique.	Six months after surgey

Collaborators and Investigators

• Sponsor: Péterfy Sándor Hospital
• Investigators: Principal Investigator: Marcell Varga, PhD, Péterfy Hospital, National Trauma Center,Budapest

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: children; fracture; bioabsorbable; radius; wire
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 228-01-CIP-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No