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Completed

NCT Number: NCT04218591

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

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

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Key information

Conditions

Thumb Osteoarthritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hand Surgery Södersjukhuset

Stockholm, S-11883, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PRP

Other

Platelet rich plasma

Placebo

Other

Saline

Primary outcomes

  1. Change in patient-rated pain on load

    Time frame: 3 and 6 months after injection.

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

Secondary outcomes

  1. Change in Nelson Thumb score

    Time frame: 3 and 6 months after injection.

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

  2. Change in EQ-5D

    Time frame: 3 and 6 months after injection.

    Weight mean value: 0=dead, 1= healthy

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

    Time frame: 3 and 6 months after injection.

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

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

    Time frame: 3 and 6 months after injection.

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

  5. Change in Hospital Anxiety and Depression Score (HADS),

    Time frame: 3 and 6 months after injection.

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

  6. Change in Pain Catastrophizing Score (PCS).

    Time frame: 3 and 6 months after injection.

    0-52p, higher score = more pain catastrophizing

  7. Change in thumb range of motion

    Time frame: 3 and 6 months after injection.

    Radial and palmar abduction of the first metacarpal (degrees)

  8. Change in thumb strength

    Time frame: 3 and 6 months after injection.

    Key pinch and pinch strength (Kg)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2020
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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