A Study on the Effect of Platelet Rich Plasma (PRP) on Os... | NCT04218591

Studies
A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

NCT04218591

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Jan 19, 2024Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Thumb Osteoarthritis

Interventions

PRP
Placebo

Countries

Sweden

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

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2020Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Dec 19, 2019

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 6, 2020Actual

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

Jan 18, 2024

Last Update Posted Date

Jan 19, 2024Actual

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

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP	Active Comparator	Intra-articular injection PRP	Other: PRP
Saline	Placebo Comparator	Intra-articular injection Saline	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP	Other	Platelet rich plasma	PRP
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in patient-rated pain on load	Numerical rating scale 0-10p (10=worst possible pain).	3 and 6 months after injection.

Secondary Outcomes

Measure	Description	Time Frame
Change in Nelson Thumb score	Patient Rated Outcome Measure, 0-100p, lower score= more disability	3 and 6 months after injection.
Change in EQ-5D	Weight mean value: 0=dead, 1= healthy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Arthritis in the thumb base.
Radiological Eaton Littler class 1-3.
Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

Exclusion Criteria:

Rheumatoid arthritis.
Ongoing infection in the hand or wrist.
History of gout or pseudo gout.
Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
Intra-articular injection in the affected joint within 6 months.
Eaton Littler class 4 (STT joint involved).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Wilcke, MD PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hand Surgery Södersjukhuset		Stockholm		S-11883	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided