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

NCT04848818 | Unknown

• 1 other identifier: 228-01-CIP-3
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Fracture Wrist

Keywords

children; radius; fracture; wire; bioabsorbable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ also reduce the postoperative immobilisation time?

  Eight weeks after operation

• Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ not require a second intervention?

  Six months after operation

• Does the short intramedullary nailing operative method with bioabsorbable Activa IM Nails™ also reduce the postoperative outpatient visits?

  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?

  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?

  Six months after surgey

Study Arms (2)

K-wire group

ACTIVE COMPARATOR

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

Activa-IM Nail group

ACTIVE COMPARATOR

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

Interventions

Distal radial metaphyseal fracture fixation with percutaneous K-wires PROCEDURE

Pediatric distal metaphyseal fractures which are severly displaced will be operated with percutaneous K-wires..

K-wire group

Distal radial and/or ulnar metaphyseal fracture fixation with bidegradable PLGA-based (Activa Im-Nail) implants PROCEDURE

Pediatric distal metaphyseal radial and /or ulnar fractures which are severly displaced will be operated with percutaneous bidegradable PLGA-based (Activa Im-Nail) implants.

Activa-IM Nail group

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Péterfy Sándor Hospital: lead

Study Sites (4)

Szent János Hospital

Budapest, Diós Árok 1., 1125, Hungary

RECRUITING

Péterfy Hospital

Budapest, Fiumei Út 17, 1081, Hungary

RECRUITING

Medical University of Pécs, Pediatric Surgery

Pécs, József Attila U 7., 7623, Hungary

RECRUITING

Heim Pál Hospital

Budapest, Üllöi Út 86, 1089, Hungary

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Fractures, Bone

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marcell Varga, PhD

  Péterfy Hospital, National Trauma Center,Budapest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcell Varga, PhD

CONTACT

0036709323027; drvmarcell@gmail.com

Tamás Kassai, MD

CONTACT

003612997700; kassai.tamas@obsi.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (4)