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Thumb tendon healing: is a cast better than early movement?

NCT ID NCT06836349

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether keeping the thumb in a cast for four weeks after surgery reduces the risk of tendon rupture compared to the standard early active motion therapy. About 380 patients in Sweden will be randomly assigned to one of the two rehab programs. The goal is to find a balance between preventing rupture and maintaining good thumb movement and strength.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rehabilitation regimen (immobilization in plaster cast vs. early active motion training)
What this could lead to
If immobilization works better, it could reduce the higher rupture rate in thumb tendon repairs while maintaining mobility and strength.
What could go wrong
This is a relatively small, early-stage registry trial, so results may not apply broadly. Immobilization might also lead to more stiffness or weaker recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2. Age over 15 years. Minors (\<18 years) are considered to have sufficient maturity to understand the implications of the research. Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury. Exclusion Criteria: Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues. Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Flexor tendon injury Flexor tendon rupture Rehabilitation program Thumb injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus

    RECRUITING

    Linköping, Sweden

  • Handkirugiska kliniken Uppsala Akademiska Sjukhus

    RECRUITING

    Uppsala, Sweden

  • Handkirurgiska kliniken Norrlands Universitetssjukhus

    RECRUITING

    Umeå, Sweden

  • Handkirurgiska kliniken Södersjukhuset

    RECRUITING

    Stockholm, Sweden

  • Handkirurgiska kliniken Örebros Universitetssjukhus

    RECRUITING

    Örebro, Sweden

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