NCT04486365

Brief Summary

To compare between bifocal and trifocal external bone transport by ilizarov ring external fixator as a treatment method for posttraumatic bone defects more than 5cm in lower extremities regarding:

  • External fixation index .
  • The need of any further surgical procedures as debridement at docking site , the need of cancellous bone graft or the use of internal fixation.
  • Functional outcome, complication rate as well as limb length discrepancy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 22, 2020

Last Update Submit

July 23, 2020

Conditions

Bone Loss

Keywords

bone transport / ilizarov ring external fixator

Outcome Measures

Primary Outcomes (1)

  • External fixation index

    the number of days the external fixator is attached to the bone per centimeter of length gained.

    12 to 15 months

Study Arms (2)

Bifocal bone transport

ACTIVE COMPARATOR

The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.

Procedure: Bifocal bone transport.

Trifocal bone transport

ACTIVE COMPARATOR

The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.

Procedure: Trifocal bone transport

Interventions

Bifocal bone transport.PROCEDURE

The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.

Bifocal bone transport
Trifocal bone transportPROCEDURE

The trifocal approach is two osteotomies creating two separate transported bone segments.

Trifocal bone transport

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • )Age from 18-60ys . 2)Posttraumatic bone defects more than 5 cm. 3)Lower extremity bone defects.

You may not qualify if:

  • )Young pts \<18 or old pts\>60. 2)Post infectious or post-resection of a tumor bone defects. 3)Upper extremity bone defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. doi: 10.1007/s00113-002-0529-x. German.

    PMID: 12376892BACKGROUND

  • Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.

    PMID: 16814787BACKGROUND

  • Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.

    PMID: 11514768BACKGROUND

  • Giannoudis PV, Papakostidis C, Roberts C. A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br. 2006 Mar;88(3):281-9. doi: 10.1302/0301-620X.88B3.16465. No abstract available.

    PMID: 16497997BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Khaled Mohsen, Bachelor

CONTACT

01065699144kmm1821995@gmail.com

Ahmed Ekram, MD

CONTACT

01012756356ahmed.osman@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician in orthopedic surgery department.

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 24, 2020

Record last verified: 2020-07