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NCT Number: NCT04210687

Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Thumb Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, S-11883, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
  • Pain at rest.
  • Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)

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

trapeziometacarpal limited excision

Procedure

Narrow pseudarthrosis CMC1

Trapeziectomy

Procedure

Simple trapeziectomy

Primary outcomes

  1. Change in pain on load NRS (numerical rating scale)

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively

Secondary outcomes

  1. Change in Nelson Thumb score

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    0-100 p, higher score = less disability

  2. Change in EQ-5D

    Time frame: 1, 3 and 5 years postoperatively

    Weight mean value: 0=dead, 1= healthy

  3. Change in DASH - Disability of the Arm, Shoulder and Hand

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    0-100 p, higher score = more disability

  4. Change in PRWHE - Patient-Rated Wrist and Hand Evaluation

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    0-100 p, higher score = more disability

  5. Change in HADS - Change hospital Anxiety and Depression score

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

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

  6. Change in PCS - Pain Catastrophizing Score

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    0-52, higher score = more pain catastrophizing

  7. Change in Thumb base motion

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    radial and palmar abduction of the first metacarpal (degrees).

  8. Change in thumb strength

    Time frame: Preoperatively, 1, 3 and 5 years postoperatively

    Key pinch and pinch strength (Kg)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Dec 26, 2019
Registry last updated
Jun 3, 2025

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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