Condition category
Musculoskeletal Diseases
Date applied
29/04/2016
Date assigned
09/05/2016
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteonecrosis is a disease caused by reduced blood flow to the bones in the joints. The bone starts to die and may break down. Osteonecrosis can affect the femoral head, which is the highest part of the thigh bone that “plugs into” the hip socket. Extracorporeal shockwave therapy (ESWT) is a procedure where a device passes sound waves through the skin to the affected bone, improving the blood flow. This study investigates the effects of different doses of ESWT on patients with early osteonecrosis of the femoral head (ONFH).

Who can participate?
Patients aged over 18 with ONFH

What does the study involve?
Participants are randomly allocated into three groups which receive different doses of ESWT. Participants are assessed with x-ray and MRI scans, and blood samples are taken.

What are the possible benefits and risks of participating?
ESWT may relieve pain and improve hip function.

Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
August 2011 to July 2015

Who is funding the study?
Chang Gung Medical Foundation (Taiwan)

Who is the main contact?
Dr Ching-Jen Wang
w281211@adm.cgmh.org.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ching-Jen Wang

ORCID ID

Contact details

123
Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan
+886 (0)7 7335279
w281211@adm.cgmh.org.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

98-2554A3

Study information

Scientific title

Extracorporeal shockwave technology in hip necrosis: a dosage validation and systemic concentrations of serum NO levels of angiogenesis and osteogenesis factors and other biomarkers

Acronym

Study hypothesis

The etiology of osteonecrosis of the femoral head (ONFH) is multi-factorial, and the treatment is disease stage dependent. Core decompression with or without bone grafting for symptomatic early stage ONFH, and total hip replacement for late stage of the disease are considered the gold standards. However, the results of core decompression are inconsistent and unpredictable despite of good results reported in selective series, and many patients eventually undergo hip replacement surgery. Therefore, an effective non-invasive method of treatment is imperative and attractive for patients with early ONFH.

This study investigated the systemic and local effects of different dosages of extracorporeal shockwave therapy (ESWT) in early osteonecrosis of the femoral head (ONFH).

Ethics approval

The Institutional Review Board of Chang Gung Memorial Hospital, 25/03/2010, IRB no: 98-2554A3

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteonecrosis of the femoral head

Intervention

The initial protocol intends to recruit 60 patients. Patients are randomly divided into three groups with 20 patients in group I who receive 2000 impulses of ESWT at 24 Kv; 20 patients in group II who receive 4000 impulses of ESWT at 24 Kv and 20 patients in group III who receive 6000 impulses of ESWT at 24 Kv.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. The number of total hip arthroplasty (THA) performed during the study period (1 year)
2. Pain (VAS) score and Harris hip score
3. Changes on X-ray and MRI studies

Secondary outcome measures

Ten milliliters of peripheral blood are obtained for measurements of serum NO level, VEGF and TGF-α; BMP-2, osteocalcin, DKK-1, IGF and IL-6 before treatment and at 1, 3, 6 and 12 months after treatment.

Overall trial start date

01/08/2011

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. ONFH in stage I, stage II or stage III-a according to ARCO classification at initial presentation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients with late stages of the disease (stages III-b, III-c or stage IV)
2. Patients under 18 years of age
3. Patients with cardiac arrhythmia or pacemaker
4. Patients on immunosuppressant drugs
5. Patients with infection or advanced arthritis
6. Patients with coagulopathy
7. Chronic renal failure
8. Pregnancy
9. Poor compliant patients

Recruitment start date

24/10/2011

Recruitment end date

24/07/2015

Locations

Countries of recruitment

Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital
123, Ta Pei Road Niao Sung District
Kaohsiung
83305
Taiwan

Sponsor information

Organisation

Chang Gung Medical Foundation (Taiwan)

Sponsor details

123
Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Chang Gung Medical Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Taiwan

Results and Publications

Publication and dissemination plan

To be confirmed at later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes