NCT00875992

Brief Summary

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

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

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

3.2 years

First QC Date

April 3, 2009

Last Update Submit

January 22, 2013

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

  • Time to pain free full weight bearing

    1 year

Secondary Outcomes (1)

  • Amount of partial weight bearing

    Up to achievement of primary outcome

Study Arms (2)

ETN with ASLS

EXPERIMENTAL

Angle stable locking of the Expert Tibial Nail using ASLS

Device: ETN with ASLS

ETN with conventional locking

ACTIVE COMPARATOR

Conventional locking of the Expert Tibial Nail using conventional locking bolts

Device: ETN locked with conventional locking bolts

Interventions

ETN with ASLSDEVICE

Angle stable locking of ETN using ASLS

ETN with ASLS
ETN locked with conventional locking boltsDEVICE

Conventional surgical procedure

ETN with conventional locking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is ≥ 18 years old
  • The patient suffers from an acute distal third tibial fracture classified as:
  • AO 42 A1-A3, AO 42 B1-B3, AO 42 C1-C3, AO 43 A1-A3
  • The fracture is fixed with an Expert Tibia Nail (ETN)
  • The patient was able to walk without walking aid prior to the accident
  • The patient is able to understand and read local language at elementary level
  • The patient is willing and able to give written informed consent to participate in the study according to the CIP

You may not qualify if:

  • The patient is legally incompetent
  • Preexistent malunion or nonunion of the fracture under investigation
  • Osteotomies
  • The patient suffers from additional fractures of the lower extremities (Exception: ipsilateral fibular fracture)
  • The patient suffers from a pathologic fracture
  • The patient suffers from active malignancy
  • The patient is pregnant, breast feeding or planning to get pregnant during the study period
  • The patient suffers from a life-threatening condition
  • The patient is affected by drug or alcohol abuse
  • The patient has participated in any device related clinical trial affecting the lower extremities within the previous month
  • The patient has participated in any drug related clinical trial affecting bone healing within the previous month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medizinische Universität

Innsbruck, 6020, Austria

Location

Charité

Berlin, 13353, Germany

Location

Medizinische Hochschule

Hanover, 30625, Germany

Location

Universität des Saarlandes

Homburg/Saar, 66421, Germany

Location

Friedrich-Schiller-Universität

Jena, 07740, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

BG Unfallklinik

Tübingen, 72076, Germany

Location

Sykehuset i Vestfold HF

Tønsberg, 3103, Norway

Location

Related Publications (1)

  • Hontzsch D, Schaser KD, Hofmann GO, Pohlemann T, Hem ES, Rothenbach E, Krettek C, Attal R. Evaluation of the effectiveness of the angular stable locking system in patients with distal tibial fractures treated with intramedullary nailing: a multicenter randomized controlled trial. J Bone Joint Surg Am. 2014 Nov 19;96(22):1889-97. doi: 10.2106/JBJS.M.01355.

    PMID: 25410507DERIVED

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Dankward Hoentzsch, MD

    BG Unfallklinik Tübingen, 72076 Tübingen, Germany

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

DE(6)AU(1)NO(1)