Condition category
Musculoskeletal Diseases
Date applied
04/09/2018
Date assigned
22/10/2019
Last edited
22/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteomyelitis is infection and inflammation of the bone or bone marrow. Surgery and open fractures are the main causes of this disease. Long-lasting (chronic) osteomyelitis often causes death (necrosis) of soft tissues (for example muscle) and bone. The dead bone can provide a place for harmful bacteria to grow and hide from antibiotics in the blood. The first step of treating chronic osteomyelitis is cutting out all infected bone and soft tissue, which often causes massive bone loss and limb shortening. Distraction osteogenesis is a process used to lengthen the long bones of the body. The bone is separated into two sections, and the two ends of the bone are gradually moved apart using a frame attached to the sections with metal pins, allowing new bone to form in the gap. This technique has gradually become a widely used treatment for osteomyelitis of the shin bone (tibia). But one of the most common problems of this method is the long treatment time, which means there is greater potential for complications, such as infection complications. In order to shorten the treatment time and reduce complications, we use L-shaped corticotomy (vertical bone splitting) to reserve half of the bone with its blood supply.The we gradually move the splitting part to fill the gap caused by the infected bone removal.

Who can participate?
Adult patients with chronic tibial osteomyelitis

What does the study involve?
All the patients will undergo the technique of L-shaped corticotomy with partial bone sliding. A researcher will perform a clinical assessment and make a record of any complications every month. Functional outcome and quality of life will be collected post-operation.

What are the possible benefits and risks of participating?
The potential benefits are shorter treatment time and fewer complications. The potential risks include infection and failure of the bone to grow.

Where is the study run from?
Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

When is the study starting and how long is it expected to run for?
August 2007 to July 2015

Who is funding the study?
Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Who is the main contact?
Pei Han
Hanpei_cn@163.com

Trial website

Contact information

Type

Public

Primary contact

Dr Pei Han

ORCID ID

Contact details

600 Yishan road
Shanghai 200233
Shanghai
0086
China
+86 (0)18930173620
hanpei_cn@163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

L-shaped corticotomy with bone flap sliding in the management of chronic tibial osteomyelitis: Surgical Technique and Clinical Results

Acronym

Study hypothesis

The technique of L-shaped corticotomy with vascularized bone flap sliding can preserve blood supply from both the osteotomic and debridement area to the largest possible extent and increase the bone contact area, thus shortening the duration of Ilizarov distraction device and solving the problems caused by traditional method of bone transport.

Ethics approval

Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, 10/02/2017, 2017-167

Study design

Observational retrospective study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic tibial osteomyelitis

Intervention

L-shaped corticotomy with bone flap sliding

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. The external fixation time (EFT) represented the total number of days the external fixator was attached to the bone, calculated at the last follow-up
2. The external fixation index (EFI), defined as the duration of external fixation in days divided by the total amount of lengthening in cm, calculated at the last follow-up

Secondary outcome measures

1. Pin tract inflammation was made according to Dahl’s grading every month after surgery
2.. Bone healing criteria according to the criteria of Paley at the last follow-up
3.. Bone functional results according to the criteria of Paley at the last follow-up
4. Rate of bridging of at least three out of four cortices assessed by X-ray prior to the segmental excision and then at 2-weekly intervals.
5. Impact of the musculoskeletal condition assessed using Short-form Musculoskeletal Function Assessment (SMFA) questionnaire at 2, 12 and 25 weeks
6. Quality of life assessed using the 36-item Short Form Health Survey (SF36) at 2, 12 and 25 weeks
7. Pain assessed using a visual analogue scale (VAS) with results taken in line with standard care

Overall trial start date

05/08/2007

Overall trial end date

15/07/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Patients with chronic osteomyelitis only involving the anterior tibial cortex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Diffuse osteomyelitis affecting both anterior and posterior cortices of the tibia
2. Severe neuro-vascular damage or mental disease or any other conditions which might lead to lack of cooperation

Recruitment start date

07/08/2007

Recruitment end date

12/11/2014

Locations

Countries of recruitment

China

Trial participating centre

Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
600 Yishan road, Shanghai 200233
Shanghai
0086
China

Sponsor information

Organisation

Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Sponsor details

600 Yishan road
Shanghai 200233
Shanghai
0086
China
+86 (0)18702121780
1522675605@qq.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will report the study results 1 year after the trial has ended.

IPD sharing statement:
The data will be available on request from Pei Han (Hanpei_cn @163.com).

Intention to publish date

29/10/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes