Hand InjuriesPOEMNCT04561661
Percutaneous Pinning vs Orthosis and Early Mobilization
A study testing Percutaneous pinning and Conservative treatment in people with Hand Injuries and Finger Fracture, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries, Finger Fracture
- What is being tested?
- Percutaneous pinning and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Fractures of the base phalanx of digit 2-5 in the hand.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Dept Hand Surgery
Stockholm
Maria Wilcke, MD, PhD, +4686162022, maria.wilcke@ki.se
About this study
Official title: A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
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.
Read the 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.
- Conditions
- Hand Injuries, Finger Fracture
- Being tested
- Percutaneous pinning, Conservative treatment
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous pinningProcedure or surgery
Closed reduction, percutaneous pinning and plaster
Conservative treatmentProcedure or surgery
Closed reduction, custom made orthosis and early mobilization
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Fracture treated with closed reduction, custom made orthosis and early mobilization. Receives: Procedure: Conservative treatment |
| Surgery | Active comparator | Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster. Receives: Procedure: Percutaneous pinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Measured: 3 months
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Measured: 6 months
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Measured: 1 year
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Measured: 3 years
Secondary outcomes (6)
Number of sick days
Number of sick days from the intervention until full return to work.
Measured: 3 months
Patient related outcome measure DASH
Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.
Measured: 3, 6 months and 1 and 3 years
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.
Measured: 3, 6 months and 1 and 3 years
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).
Measured: 3, 6 months and 1 and 3 years
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.
Measured: 3, 6 months and 1 and 3 years
Grips strength
Measured in kilograms (JAMAR)
Measured: 3, 6 months and 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Mar 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
- Investigators
- Johanna von Kieseritzky, MD PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561661
- Sponsor's protocol ID
- Frakturstudien
- Acronym
- POEM
- Status last verified
- Jun 2025
- First submitted
- 14 Sep 2020
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
- ClinicalTrials.gov ID
- NCT04561661
- Acronym / sponsor ID
- POEM / Frakturstudien
- Conditions
- Hand Injuries, Finger Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Procedure: Conservative treatmentFracture treated with closed reduction, custom made orthosis and early mobilization. |
| Surgery | Active comparator | Procedure: Percutaneous pinningFractures treated with closed reduction, percutaneous pinning (k-wires) and plaster. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Fractures of the base phalanx of digit 2-5 in the hand.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous pinningClosed reduction, percutaneous pinning and plaster | Procedure or surgery | Surgery |
| Conservative treatmentClosed reduction, custom made orthosis and early mobilization | Procedure or surgery | Conservative treatment |
Primary outcome
TAM (Total active range of motion)
Time frame: 3 months
Total active range of motion measured in degrees of the affected finger.
TAM (Total active range of motion)
Time frame: 6 months
Total active range of motion measured in degrees of the affected finger.
TAM (Total active range of motion)
Time frame: 1 year
Total active range of motion measured in degrees of the affected finger.
TAM (Total active range of motion)
Time frame: 3 years
Total active range of motion measured in degrees of the affected finger.
6 secondary outcomes
Number of sick days
Time frame: 3 months
Patient related outcome measure DASH
Time frame: 3, 6 months and 1 and 3 years
Patient related outcome measure HADS
Time frame: 3, 6 months and 1 and 3 years
Patient related outcome measure EQ-5D
Time frame: 3, 6 months and 1 and 3 years
Patient related outcome measure HQ-8
Time frame: 3, 6 months and 1 and 3 years
Grips strength
Time frame: 3, 6 months and 1 and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johanna von Kieseritzky, MD PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous pinning and Conservative treatment in people with Hand Injuries and Finger Fracture, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik Alfort, MD (+46704044648, henrik.alfort@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAM (Total active range of motion) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.