NCT04218591

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

3.9 years

First QC Date

December 19, 2019

Last Update Submit

January 18, 2024

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change in patient-rated pain on load

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

    3 and 6 months after injection.

Secondary Outcomes (8)

  • Change in Nelson Thumb score

    3 and 6 months after injection.

  • Change in EQ-5D

    3 and 6 months after injection.

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

    3 and 6 months after injection.

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

    3 and 6 months after injection.

  • Change in Hospital Anxiety and Depression Score (HADS),

    3 and 6 months after injection.

  • +3 more secondary outcomes

Study Arms (2)

PRP

ACTIVE COMPARATOR

Intra-articular injection PRP

Other: PRP

Saline

PLACEBO COMPARATOR

Intra-articular injection Saline

Other: Placebo

Interventions

PRPOTHER

Platelet rich plasma

PRP
PlaceboOTHER

Saline

Saline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hand Surgery Södersjukhuset

Stockholm, S-11883, Sweden

Location

Study Officials

  • Maria Wilcke, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 6, 2020

Study Start

February 24, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)