Osteochondral Lesion of TalusNCT03750253
Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
A study testing Extracorporeal Shock Wave Therapy in people with Osteochondral Lesion of Talus, run by Southwest Hospital, China at 1 site in China.
Trial summary
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteochondral Lesion of Talus
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For arthroscopy:
- Ankle pain, aggravated after exercise or weight-bearing activity, accompanied by lameness, joint stiffness and dysfunction for at least 3 months
- No talar collapse
- Talar cartilage injury cases before stage Ⅳ of Hepple classification
- For shock wave therapy:
- Patients with micro-fractures treated with arthroscopic treatment of talar cartilage injury and were treated with routine rehabilitation training after arthroscopy
- Patients who till complained obvious ankle pain 3 months after surgery
Who cannot join
- Severe cardiovascular and cerebrovascular diseases
- Hemorrhagic diseases, coagulation disorders
- Bone immaturity
- Thrombosis
- Use of anti-immune agents
- Various types of tumor patients
Show all 10Show fewer
- Pregnant women
- History of mental illness
- Patients who could not be followed
- Patients with other lower extremity injuries after surgery and were unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.
Read the detailed description
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy.
Patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. Radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by Magnetic Resonance Imaging(MRI) of the ankle.
- Conditions
- Osteochondral Lesion of Talus
- Being tested
- Extracorporeal Shock Wave Therapy
- Keywords
- Extracorporeal Shock Wave Therapy, Osteochondral Lesions of Talus, Arthroscopy, Pain-relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyOther
Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Other | Extracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus Receives: Other: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VAS scores before and after shock wave therapy
The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.
Measured: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
Secondary outcomes (1)
Change of AOFAS scores before and after shock wave therapy
The American Orthopaedic Foot \& Ankle Society scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.
Measured: 6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Mar 2013
- Primary completion1 Feb 2019
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Duan, Southwest Hospital, China
- Investigators
- Xiaojun Duan, M.D., Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750253
- Sponsor's protocol ID
- ESWT
- Status last verified
- Mar 2019
- First submitted
- 18 Nov 2018
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock Wave Therapy for Pain-Relief After Arthroscopy for Osteochondral Lesions of the Talus
- ClinicalTrials.gov ID
- NCT03750253
- Acronym / sponsor ID
- ESWT
- Conditions
- Osteochondral Lesion of Talus
- Keywords
- Extracorporeal Shock Wave Therapy, Osteochondral Lesions of Talus, Arthroscopy, Pain-relief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study aims to investigate the clinical efficacy of shock wave adjuvant therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy and to provide basis for further popularization and application.
Detailed description
Arthroscopic surgery is effective in treating osteochondral lesions of the talus. However, there are still some patients with postoperative ankle pain. This study was conducted to investigate the clinical efficacy of shock wave therapy in the treatment of postoperative pain caused by cartilage injury of talus after arthroscopy.
Patients with osteochondral lesions of the talus treated by arthroscopic microfracture surgery and still complained ankle pain three months after surgery were enrolled. Radial extracorporeal shock wave therapy was used to give energy to the injured region of the talus and the adjacent area.Treatment was done once a week for 5 consecutive weeks. After shock wave therapy,the patients were followed by Visual Analogue Scale (VAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot scale(AOFAS-AHFS) , and followed finally by Magnetic Resonance Imaging(MRI) of the ankle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Other | Other: Extracorporeal Shock Wave TherapyExtracorporeal Shock Wave Therapy to relieve pain after arthroscopy for osteochondral lesions of talus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For arthroscopy:
- For shock wave therapy:
Key exclusion criteria (10 listed)
- Severe cardiovascular and cerebrovascular diseases
- Hemorrhagic diseases, coagulation disorders
- Bone immaturity
- Thrombosis
- Use of anti-immune agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyExtracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus | Other | Extracorporeal Shock Wave Therapy |
Primary outcome
Change of VAS scores before and after shock wave therapy
Time frame: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy
The Visual Analogue Scale scores of the patients before and after the shock wave therapy are recorded. The scale ranges from 0-10 points, and decreases of the value represent a better outcome. The data analyses are performed with SPSS version 16.0 statistical software. Continuous variables are expressed as mean ± standard deviation, and 95% confidence intervals are determined. The data are compared by paired t test or rank-sum test. P value < 0.05 is considered as statistically significant.
1 secondary outcome
Change of AOFAS scores before and after shock wave therapy
Time frame: 6 weeks, 12 weeks and last follow-up last follow-up at an average of 2 years after shock wave therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Duan, M.D. principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Osteochondral Lesion of Talus, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VAS scores before and after shock wave therapy (time frame: 6 weeks, 12 weeks and last follow-up at an average of 2 years after shock wave therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.