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Percutaneous Pinning vs Orthosis and Early Mobilization (POEM)

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ClinicalTrials.gov Identifier: NCT04561661
Recruitment Status : Not yet recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Wilcke, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hand Injuries Finger Fracture Procedure: Percutaneous pinning Procedure: Conservative treatment Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Conservative treatment
Fracture treated with closed reduction, custom made orthosis and early mobilization.
Procedure: Conservative treatment
Closed reduction, custom made orthosis and early mobilization

Active Comparator: Surgery
Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.
Procedure: Percutaneous pinning
Closed reduction, percutaneous pinning and plaster




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561661


Contacts
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Contact: Henrik Alfort, MD +46704044648 henrik.alfort@ki.se

Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Johanna von Kieseritzky, MD PhD Karolinska Institutet
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Responsible Party: Maria Wilcke, MD, Phd, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04561661    
Other Study ID Numbers: Frakturstudien
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hand Injuries
Wounds and Injuries