Dosage effects of extracorporeal shockwave therapy in early hip necrosis
| ISRCTN | ISRCTN74606904 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74606904 |
| Secondary identifying numbers | 98-2554A3 |
- Submission date
- 29/04/2016
- Registration date
- 09/05/2016
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
123, Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan
| Phone | +886 (0)7 7335279 |
|---|---|
| w281211@adm.cgmh.org.tw |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | The Institutional Review Board of Chang Gung Memorial Hospital, 25/03/2010, IRB no: 98-2554A3 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/08/2011 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 33 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/10/2011 |
| Date of final enrolment | 24/07/2015 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Niao Sung District
Kaohsiung
83305
Taiwan
Sponsor information
Hospital/treatment centre
123, Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan
"ROR" |
https://ror.org/02verss31 |
|---|
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | 02/09/2020 | Yes | No |
Editorial Notes
02/09/2020: Publication reference and total final enrolment number added.
