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

Primary Purpose

Thumb Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

PRP

Placebo

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis

Eligibility Criteria

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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).

Sites / Locations

Department of Hand Surgery SödersjukhusetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PRP

Saline

Arm Description

Intra-articular injection PRP

Intra-articular injection Saline

Outcomes

Primary Outcome Measures

Change in patient-rated pain on load

Numerical rating scale 0-10p (10=worst possible pain).

Secondary Outcome Measures

Change in Nelson Thumb score

Patient Rated Outcome Measure, 0-100p, lower score= more disability

Change in EQ-5D

Weight mean value: 0=dead, 1= healthy

Change in Patient-rated Wrist and Hand Evaluation (PRWHE)

Patient Rated Outcome Measure 0-100p, higher score=more disability

Change in Disability of the Hand, Arm and Shoulder (DASH) score

Patient Rated Outcome Measure, 0-100p higher score=more disability

Change in Hospital Anxiety and Depression Score (HADS),

2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse

Change in Pain Catastrophizing Score (PCS).

0-52p, higher score = more pain catastrophizing

Change in thumb range of motion

Radial and palmar abduction of the first metacarpal (degrees)

Change in thumb strength

Key pinch and pinch strength (Kg)

Full Information

NCT ID

NCT04218591

First Posted

December 19, 2019

Last Updated

October 10, 2023

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT04218591

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2020 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thumb Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRP

Arm Type

Active Comparator

Arm Description

Intra-articular injection PRP

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Intra-articular injection Saline

Intervention Type

Other

Intervention Name(s)

PRP

Intervention Description

Platelet rich plasma

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Saline

Primary Outcome Measure Information:

Title

Change in patient-rated pain on load

Description

Numerical rating scale 0-10p (10=worst possible pain).

Time Frame

3 and 6 months after injection.

Secondary Outcome Measure Information:

Title

Change in Nelson Thumb score

Description

Patient Rated Outcome Measure, 0-100p, lower score= more disability

Time Frame

3 and 6 months after injection.

Title

Change in EQ-5D

Description

Weight mean value: 0=dead, 1= healthy

Time Frame

3 and 6 months after injection.

Title

Change in Patient-rated Wrist and Hand Evaluation (PRWHE)

Description

Patient Rated Outcome Measure 0-100p, higher score=more disability

Time Frame

3 and 6 months after injection.

Title

Change in Disability of the Hand, Arm and Shoulder (DASH) score

Description

Patient Rated Outcome Measure, 0-100p higher score=more disability

Time Frame

3 and 6 months after injection.

Title

Change in Hospital Anxiety and Depression Score (HADS),

Description

2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse

Time Frame

3 and 6 months after injection.

Title

Change in Pain Catastrophizing Score (PCS).

Description

0-52p, higher score = more pain catastrophizing

Time Frame

3 and 6 months after injection.

Title

Change in thumb range of motion

Description

Radial and palmar abduction of the first metacarpal (degrees)

Time Frame

3 and 6 months after injection.

Title

Change in thumb strength

Description

Key pinch and pinch strength (Kg)

Time Frame

3 and 6 months after injection.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Wilcke, MD PhD

Phone

0708294613

Ext

0708294613

maria.wilcke@sll.se

First Name & Middle Initial & Last Name or Official Title & Degree

Kajsa Evans, MD

kajsa.evans@regionstockholm.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Wilcke, MD PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hand Surgery Södersjukhuset

City

Stockholm

ZIP/Postal Code

S-11883

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Wilcke, PhD

Phone

+46708294613

maria.wilcke@regionstockholm.se

First Name & Middle Initial & Last Name & Degree

Johanna Von Kieseritzky, PhD

johanna.vonkieseritzky@regionstockholm.se

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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