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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Trapeziectomy for Thumb Osteoarthritis

A multi-center randomly assigned compared with a dummy treatment clinical trial which determines the how well it works of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.

Official registry: https://clinicaltrials.gov/study/NCT05127005 · Tampere University Hospital · enrollment listed as 132

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trapeziectomy, or Sham. The registry lists allocation as randomized. A multi-center randomly assigned compared with a dummy treatment clinical trial which determines the how well it works of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb.

They plan to enroll about 132 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

Interventions: Trapeziectomy, Sham

Primary outcome (registry wording): Patient rated wrist and hand evaluation (PRWHE)

Who it is for (from inclusion criteria)

  • Ages 45 Years to any
  • Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living
  • Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months
  • Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
  • ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
  • Ability to speak, understand and read in the language of the clinical site
  • Shared decision to proceed with surgical treatment of CMC-1 OA

Public study contact (from the registry)

Jarkko Jokihaara

+3583311611

jarkko.jokihaara@pirha.fi

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

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NCT04375280 · Official ClinicalTrials.gov record · University Hospital, Clermont-Ferrand

FAQ about this NCT record

Is NCT05127005 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05127005?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05127005?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary