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3 RECOA meeting 2009

Low-intensity pulsed ultrasound

treatment of delayed unions andnonunions

Peter Nolte, MD PhD

Spaarne HospitalHoofddorp

The Netherlands

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Nonunion

Disturbed fracture healing

Localisation

6 - 9 months post-fracture = nonunion(pseudarthrosis)

1% of all fractures

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Nonunion

Definition:

failure bone healing

> 6 months andstop of all bone

healing processes

HypertrophicNormotrophic

Atrophic

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Nonunion

Cause?

Fracture (treatment) characteristics

Patient characteristics

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Nonunion

Operative treatment:

Stability

Healthy tissue

Sufficient bloodsupply

Concepts and Cases in Nonunion Treatment 2009

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Nonunion treatment

Surgery

stabilization

biomechanical

compression

Biological

invasive (Bone graft, BMP)

non-invasive (Shock wave, PEMF, LIPUS)

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LIPUS

Exogen device

Pulse width200ms

Pulsed at 1kHz

Frequency 1.5MHz

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LIPUS

Animal experiments

Ultrasound ControlNaruse et al J Bone Min Res 2003;18:360-9

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LIPUS

clinical trials fractures

Busse et al BMJ 2009;338:b351

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LIPUS

Animal nonunion study

Takikawa ea 2001

Rat tibia fracture and muscle interposition

LIPUS 50% (7/14) healing

Control 0% healing

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Nonunion LIPUS treatment

Nolte 2001 mixed 86% (25/29)

Fujioka 2004 hamate 100% (2/2)Gebauer 2005 mixed 85% (57/67)

Jones 2006 hindfoot 77% (13/18)

Jingushi 2007 mixed 75%(54/72)

Rutten 2007 tibia 73%(52/71)

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LIPUS in the treatment of

nonunionsProspective,

Non-randomized,

Case control study

Journal of Trauma 2001; 51(4):693-702

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LIPUS in the treatment of

nonunionsResults

Avg 5 months

25/29 healed (86%)

Journal of Trauma 2001; 51(4):693-702

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LIPUS in the treatment of

nonunions

Results

Analysis of 4 failures:-ankle arthrodesis for arthritis

-femur im nailing, healed after 1 year

-ulna plate, healed after 6 months

-scaphoid lost to follow up

Smoking, Instability,And Device compliance

Journal of Trauma 2001; 51(4):693-702

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Use of LIPUS for postraumaticnonunions of the tiba: a review of

patients treated in the Netherlands

Healing rate is 73%(52/71).

LIPUS - Spontaneous healing( p < 0.0001).

Stratification: no significant variable

Long-term follow-up

high compliance rate

no refractures.Journal of Trauma 2007; 62(4):902-8

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Osteotomy stimulation by

UltrasoundCorrection osteotomy

lower extremity

Double-blinded,clinical, randomizedstudy of lowintensity pulsedultrasound

Nolte PhD Thesis 2002

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Osteotomy stimulation by

UltrasoundResults

Baseline characteristics:

Age, gender,Osteotomy, smoking

Comparable

active - placebo

Nolte PhD Thesis 2002

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Osteotomy stimulation by

UltrasoundResults [weeks to consolidation]

Osteotomy Placebo Active

metaphysis 21 16

diaphysis 38 24

Total 28 19

(p

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Osteotomy stimulation by

UltrasoundResults

Baseline comparison of active placebo

Fibula OT

Nonunion development

Significant difference

Nolte PhD Thesis 2002

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LIPUS Treatment in Fibula

Nonunion

20 patients high tibial osteotomy

6 months fibula nonunion

Prospective randomized placebo controlledtrial

LIPUS/placebo 5 months

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LIPUS Treatment in Fibula

Nonunion

Acceleration of bone healing in fibula

nonunion

29%

Control

LIPUS

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LIPUS Treatment in Fibula

Nonunion

Fibula biopsy

3 months

LIPUS/placebo

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LIPUS increases bone volume, osteoidthickness and MAR in the area of bone

healing in patients with a delayed unionof the fibula

Histomorphometry

LIPUS accelerates clinical fracture healing byincreasing osteoblast activity. Direct boneformation was only observed in the LIPUS-treated delayed unions, which might beexplained by increased neovascularizationand/or stability.

Rutten et al Bone 2008;43:348-54

New Bone Cancellous bone Cortical bone

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LIPUS Treatment in

Nonunions

LIPUSPEMF

Clinical effect the same

LIPUS more evidence in RCT

LIPUS more easy to apply

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LIPUS Treatment in

Nonunions

Hypertrophic Nonunion --> stability

sometimes LIPUS

Normotrophic/Atrophic --> stability andbone graft

often LIPUS

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LIPUS Treatment in

Nonunions

Recognition of at risk patients

Combination with bone graft or BMP?

Evaluation of LIPUS treatment after

3 months