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Percutaneous Pinning vs Orthosis and Early Mobilization (POEM)

Primary Purpose

Hand Injuries, Finger Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Percutaneous pinning
Conservative treatment
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dept Hand SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conservative treatment

Surgery

Arm Description

Fracture treated with closed reduction, custom made orthosis and early mobilization.

Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of sick days
Number of sick days from the intervention until full return to work.
Patient related outcome measure DASH
Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.
Patient related outcome measure HADS
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.
Patient related outcome measure EQ-5D
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).
Patient related outcome measure HQ-8
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.
Grips strength
Measured in kilograms (JAMAR)

Full Information

First Posted
September 14, 2020
Last Updated
October 10, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04561661
Brief Title
Percutaneous Pinning vs Orthosis and Early Mobilization
Acronym
POEM
Official Title
A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Finger Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Fracture treated with closed reduction, custom made orthosis and early mobilization.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous pinning
Intervention Description
Closed reduction, percutaneous pinning and plaster
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment
Intervention Description
Closed reduction, custom made orthosis and early mobilization
Primary Outcome Measure Information:
Title
TAM (Total active range of motion)
Description
Total active range of motion measured in degrees of the affected finger.
Time Frame
3 months
Title
TAM (Total active range of motion)
Description
Total active range of motion measured in degrees of the affected finger.
Time Frame
6 months
Title
TAM (Total active range of motion)
Description
Total active range of motion measured in degrees of the affected finger.
Time Frame
1 year
Title
TAM (Total active range of motion)
Description
Total active range of motion measured in degrees of the affected finger.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of sick days
Description
Number of sick days from the intervention until full return to work.
Time Frame
3 months
Title
Patient related outcome measure DASH
Description
Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.
Time Frame
3, 6 months and 1 and 3 years
Title
Patient related outcome measure HADS
Description
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.
Time Frame
3, 6 months and 1 and 3 years
Title
Patient related outcome measure EQ-5D
Description
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).
Time Frame
3, 6 months and 1 and 3 years
Title
Patient related outcome measure HQ-8
Description
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.
Time Frame
3, 6 months and 1 and 3 years
Title
Grips strength
Description
Measured in kilograms (JAMAR)
Time Frame
3, 6 months and 1 and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Alfort, MD
Phone
+46704044648
Email
henrik.alfort@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna von Kieseritzky, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Dept Hand Surgery
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Wilcke, MD, PhD
Phone
+4686162022
Email
maria.wilcke@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Percutaneous Pinning vs Orthosis and Early Mobilization

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