Effect of Extracorporeal Shock Wave in the Treatment of K... | NCT03962270

Studies
Effect of Extracorporeal Shock Wave in the Treatment of Knee Osteoarthritis

NCT03962270

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

May 24, 2019Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis
Cartilage Injury

Interventions

shock wave device

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Aug 1, 2019Estimated

Completion Date

Aug 1, 2019Estimated

First Submitted Date

Oct 30, 2018

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2019

Last Update Posted Date

May 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mouwang Zhou, senior professional post, Peking University Third HospitalPrincipal Investigator

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the effectiveness of ESWT in the treatment of knee OA was investigated from the perspective of cartilage injury，and to prove that shockwave could delay the early and middle stage OA progression by improving cartilage condition

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental		Device: shock wave device
Control group	Sham Comparator		Device: shock wave device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
shock wave device	Device	The experimental group (group ESWT) guided by ultrasound: conventional rehabilitation training is given priority to with strength training, application of pain when necessary, under the guidance of ultrasound ESWT treatment control group (routine rehabilitation group) : conventional rehabilitation training is given priority to with strength training, oral pain when necessary, under the guidance of ultrasound ESWT treatment (shock energy flow density of 0)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
magnetic resonance imaging of knee	t2 mapping	Baseline (before treatment)
magnetic resonance imaging of knee	t2 mapping	Three months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Knee joint ROM normal or near normal: flexion 110 ° or reach 0 ° or less
MR prompt exist cartilage damage, there is no lack of full-thickness cartilage
Kellgren - Lawrence (K - L) grade II - III grade
The international association of cartilage repair cartilage damage grading system (ICRS) class I - III
Informed consent and sign relevant documents
Follow doctor's instructions and follow up on time

Exclusion Criteria:

Metabolic arthritis
Trauma of bone joint
Inflammatory diseases
Previous knee surgery history
History of knee cavity injection in the past 6 months
Serious cardiovascular diseases, pulmonary diseases or other serious diseases affecting survival, etc

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mouwang 谋望 zhou, master	Contact	13910092892	周	zhoumouwang@163.com
mingzhen 明真 Lee, bachelor	Contact	18810334425	李	mingzhenli@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Univercity Third Hospital	Recruiting	Beijing	No State Or Province	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided