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NCT Number: NCT04561661

Percutaneous Pinning vs Orthosis and Early Mobilization

This study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. This will be achieved through a randomised clinical trial comparing the two methods.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Proximal phalangeal fractures of the hand are very common and affect patients of all ages. . Most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. If there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. Surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. Good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. This study will compare these two methods for treating fractures of the base phalanx of the fingers. Recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. Primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. Secondary outcomes are number of sick days and various patient related outcome measures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Fractures of the base phalanx of digit 2-5 in the hand.

Exclusion criteria

  • Fracture older than 2 weeks.
  • More than 25° of sagittal plane and/or 10° lateral angulation after reposition.
  • Intra-articular step >1mm.
  • Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger.
  • Open fractures.
  • Patient age <18 years.
  • Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).

Treatment and study plan

Percutaneous pinning

Procedure

Closed reduction, percutaneous pinning and plaster

Conservative treatment

Procedure

Closed reduction, custom made orthosis and early mobilization

Primary outcomes

  1. TAM (Total active range of motion)

    Time frame: 3 months

    Total active range of motion measured in degrees of the affected finger.

  2. TAM (Total active range of motion)

    Time frame: 6 months

    Total active range of motion measured in degrees of the affected finger.

  3. TAM (Total active range of motion)

    Time frame: 1 year

    Total active range of motion measured in degrees of the affected finger.

  4. TAM (Total active range of motion)

    Time frame: 3 years

    Total active range of motion measured in degrees of the affected finger.

Secondary outcomes

  1. Number of sick days

    Time frame: 3 months

    Number of sick days from the intervention until full return to work.

  2. Patient related outcome measure DASH

    Time frame: 3, 6 months and 1 and 3 years

    Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.

  3. Patient related outcome measure HADS

    Time frame: 3, 6 months and 1 and 3 years

    Hospital Anxiety and Depression Scale (HADS). The score is consists of one depression scale from 0 to 21, where 0 is no signs of depression and one anxiety scale from 0 to 21, where 0 means no anxiety.

  4. Patient related outcome measure EQ-5D

    Time frame: 3, 6 months and 1 and 3 years

    EuroQols quality of life index. Consists of an index based on the questionnaire where 0 means death and 1 means full quality of life and one visual analog scale 0-100 where patients rate their health from bad (0) to excellent (100).

  5. Patient related outcome measure HQ-8

    Time frame: 3, 6 months and 1 and 3 years

    HQ-8 is a questionnaire specifically for hand injuries. Each question gives a score 0-100, where 0 means no problems and 100 means worst imaginable problem.

  6. Grips strength

    Time frame: 3, 6 months and 1 and 3 years

    Measured in kilograms (JAMAR)

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Alfort, MD

CONTACT

[email protected]

+46704044648

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures

Acronym: POEM

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2020
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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