3 RECOA meeting 2009

Low-intensity pulsed ultrasound

treatment of delayed unions and
nonunions

Peter Nolte, MD PhD

Spaarne Hospital
Hoofddorp
The Netherlands
 Nonunion
Disturbed fracture healing

Localisation

6 - 9 months post-fracture = nonunion

(pseudarthrosis)

1% of all fractures
 Nonunion
Definition:
failure bone healing
> 6 months and
stop of all bone
healing processes

Hypertrophic
Normotrophic
Atrophic
 Nonunion

Cause?

Fracture (treatment) characteristics

Patient characteristics
 Nonunion
Operative treatment:

Stability

Healthy tissue

Sufficient bloodsupply

Concepts and Cases in Nonunion Treatment 2009

 Nonunion treatment
Surgery
stabilization
biomechanical
compression

Biological
invasive (Bone graft, BMP)
non-invasive (Shock wave, PEMF, LIPUS)
 LIPUS

Exogen device

Pulsed at 1kHz

Pulse width
200ms Frequency 1.5MHz
 LIPUS
Animal experiments

Ultrasound Control
Naruse et al J Bone Min Res 2003;18:360-9
 LIPUS
clinical trials fractures

Busse et al BMJ 2009;338:b351

 LIPUS
Animal nonunion study

Takikawa ea 2001

Rat tibia fracture and muscle interposition

LIPUS 50% (7/14) healing

Control 0% healing
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)
 LIPUS in the treatment of
nonunions
Prospective,

Non-randomized,

Case control study

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

LIPUS in the treatment of
nonunions
Results

Avg 5 months

25/29 healed (86%)

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

 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

 Use of LIPUS for postraumatic
nonunions 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
Osteotomy stimulation by
Ultrasound
Correction osteotomy
lower extremity

Double-blinded,
clinical, randomized
study of low
intensity pulsed
ultrasound

Nolte PhD Thesis 2002

 Osteotomy stimulation by
Ultrasound
Results
Baseline characteristics:
Age, gender,
Osteotomy, smoking

Comparable
active - placebo
Nolte PhD Thesis 2002
 Osteotomy stimulation by
Ultrasound
Results [weeks to consolidation]

Osteotomy Placebo Active

metaphysis 21 16
diaphysis 38 24
Total 28 19
(p<0.001)

Nolte PhD Thesis 2002

 Osteotomy stimulation by
Ultrasound
Results
Baseline comparison of active – placebo

Fibula OT

Nonunion development

Significant difference
Nolte PhD Thesis 2002
LIPUS Treatment in Fibula
Nonunion

20 patients high tibial osteotomy

 6 months fibula nonunion

Prospective randomized placebo controlled

trial

LIPUS/placebo 5 months
LIPUS Treatment in Fibula
Nonunion

Acceleration of bone healing in fibula

nonunion

Control
LIPUS
29%
LIPUS Treatment in Fibula
Nonunion

Fibula biopsy

3 months
LIPUS/placebo
 LIPUS increases bone volume, osteoid
thickness and MAR in the area of bone
healing in patients with a delayed union
of the fibula
New Bone Cancellous bone Cortical bone
Histomorphometry

LIPUS accelerates clinical fracture healing by

increasing osteoblast activity. Direct bone
formation was only observed in the LIPUS-
treated delayed unions, which might be
explained by increased neovascularization
and/or stability.
Rutten et al Bone 2008;43:348-54
 LIPUS Treatment in
Nonunions

LIPUS<-->PEMF

Clinical effect the same

LIPUS more evidence in RCT
LIPUS more easy to apply
 LIPUS Treatment in
Nonunions

Hypertrophic Nonunion --> stability

sometimes LIPUS

Normotrophic/Atrophic --> stability and

bone graft
often LIPUS
 LIPUS Treatment in
Nonunions

Recognition of ‘at risk’ patients

Combination with bone graft or BMP?

Evaluation of LIPUS treatment after

3 months