Finger InjuriesNCT02548260
Treatment of Proximal Interphalangeal Joint Injuries. Clinical Efficiency of Syndactyly Treatment and Digital Compression
A study testing Syndactyly without compression, Syndactyly with compression and Rigid splint without compression in people with Finger Injuries, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Finger Injuries
- What is being tested?
- Syndactyly without compression, Syndactyly with compression and Rigid splint without compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- proximal interphalangeal joint injury with or without dorsal or lateral luxation
- less than seven days after injury
- injured joint stability
- fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface
Who cannot join
- palmar luxation of the proximal interphalangeal joint
- fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface
- injury to the central band of the extensor tendon
- fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface
- non reducible luxation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1005
About this study
Official title: Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression
Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. The investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.
Read the detailed description
Proximal interphalangeal joint (PIPJ) injuries of the fingers are a common occurrence. They may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. Immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain.
Injuries to the joints of the hand produce edema that is responsible for additional stiffness. Compressive garment may be worn to limit the extent of the edema and help its resorption.
Although PIPJ injuries are frequent, their treatment does not benefit from a consensus. Most studies are retrospective or aimed at a pediatric population. The investigators wish to evaluate the outcome of PIPJ injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.The investigators also wish to study the effect of finger compression on edema resolution and finger motion. Therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression.
The study will be conducted in the hand surgery unit of a university hospital in a prospective way. The assignment to a particular treatment group will be randomly performed. Patients will be followed for 6 months.
- Conditions
- Finger Injuries
- Being tested
- Syndactyly without compression, Syndactyly with compression, Rigid splint without compression, Rigid splint with compression
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndactyly without compressionDevice
three week relative immobilization by syndactyly
Syndactyly with compressionDevice
three week relative immobilization by syndactyly and compression
Rigid splint without compressionDevice
three week rigid immobilization by splint
Rigid splint with compressionDevice
three week rigid immobilization by splint and compression
| Study group | Role | What they receive |
|---|---|---|
| Syndactyly without compression | Experimental | Relative immobilization with a syndactyly (CE conformity), no compression is worn. Receives: Device: Syndactyly without compression |
| Syndactyly with compression | Experimental | Relative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger Receives: Device: Syndactyly with compression |
| Rigid splint without compression | Experimental | Rigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn Receives: Device: Rigid splint without compression |
| Rigid splint with compression | Experimental | Rigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger Receives: Device: Rigid splint with compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in digital mobility of wounded finger
Evaluation of digital mobility by measuring the palm-tip of the finger distance with a ruler. The active and passive mobility of the metacarpophalangeal, proximal and distal interphalangeal joints will be measured with a goniometer.
Measured: 3 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes (6)
Change in pain
Patient has to rate the pain in the wounded finger during the last two days using a visual analog scale.
Measured: 3 weeks, 6 weeks, 3 months, 6 months
Global function
Patient has to fill out the validated QuickDASH questionnaire relative to activities of daily living.
Measured: 3 months
Satisfaction
Patient has to rate its satisfaction with the treatment outcome on a scale from 1 to 10 (greatest satisfaction = 10)
Measured: 3 months
Cost
The cost of the whole treatment will be calculated for each patient after the final consultation at 6 months. It will include the consultations themselves, the cost of the devices used, the hand therapy, the absence from work.
Measured: six months
Change in strength
Pinch strength and global hand strength will be evaluated with specific devices (pinch and dynamometer)
Measured: 3 weeks, 6 weeks, 3 months, 6 months
Change in finger diameter
Diameter of the injured finger at the proximal interphalangeal joint will be assessed with a specific device (rings of various diameter)
Measured: 3 weeks, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger InjuriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thierry Christen, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548260
- Sponsor's protocol ID
- 301/15
- Status last verified
- Aug 2018
- First submitted
- 3 Sep 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Proximal Interphalangeal Joint Injuries. Comparative Study of the Clinical Efficiency and Cost of Syndactyly Treatment Versus Immobilization and Compression Versus no Compression
- ClinicalTrials.gov ID
- NCT02548260
- Acronym / sponsor ID
- 301/15
- Conditions
- Finger Injuries
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Sep 2015 (estimated)
- 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.
Proximal interphalangeal joint injuries of the fingers may be treated in various ways and no treatment has been shown to be superior. The investigators wish to study the effectiveness of syndactyly versus digital splint when comparing joint mobility. The investigators also wish to study the effectiveness of finger compression in reducing edema and therefore allowing a greater arc of motion.
Detailed description
Proximal interphalangeal joint (PIPJ) injuries of the fingers are a common occurrence. They may be treated various ways: strict immobilization in a finger splint for one to three weeks, syndactyly, no immobilization. Immobilization is often responsible for joint stiffness whereas immediate mobilization might produce pain.
Injuries to the joints of the hand produce edema that is responsible for additional stiffness. Compressive garment may be worn to limit the extent of the edema and help its resorption.
Although PIPJ injuries are frequent, their treatment does not benefit from a consensus. Most studies are retrospective or aimed at a pediatric population. The investigators wish to evaluate the outcome of PIPJ injury after different treatments: either strict immobilization in a rigid splint for three weeks, of relative immobilization in a syndactyly for three weeks.The investigators also wish to study the effect of finger compression on edema resolution and finger motion. Therefore there will be four treatment groups: syndactyly with and without compression, rigid splint with and without compression.
The study will be conducted in the hand surgery unit of a university hospital in a prospective way. The assignment to a particular treatment group will be randomly performed. Patients will be followed for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Syndactyly without compression | Experimental | Device: Syndactyly without compressionRelative immobilization with a syndactyly (CE conformity), no compression is worn. |
| Syndactyly with compression | Experimental | Device: Syndactyly with compressionRelative immobilization with a syndactyly (CE conformity), compression (CE conformity) is worn over the finger |
| Rigid splint without compression | Experimental | Device: Rigid splint without compressionRigid immobilization with a custom made thermoplastic splint (CE conformity), no compression is worn |
| Rigid splint with compression | Experimental | Device: Rigid splint with compressionRigid immobilization with a custom made thermoplastic splint (CE conformity), compression (CE conformity) is worn over the finger |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- proximal interphalangeal joint injury with or without dorsal or lateral luxation
- less than seven days after injury
- injured joint stability
- fracture of the palmar rim of the intermediate phalanx less than 30% of articular surface
Key exclusion criteria (5 listed)
- palmar luxation of the proximal interphalangeal joint
- fracture of the palmar rim of the intermediate phalanx greater than 30% of articular surface
- injury to the central band of the extensor tendon
- fracture other than palmar rim of the intermediate phalanx less than 30% of articular surface
- non reducible luxation
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 |
|---|---|---|
| Syndactyly without compressionthree week relative immobilization by syndactyly | Device | Syndactyly without compression |
| Syndactyly with compressionthree week relative immobilization by syndactyly and compression | Device | Syndactyly with compression |
| Rigid splint without compressionthree week rigid immobilization by splint | Device | Rigid splint without compression |
| Rigid splint with compressionthree week rigid immobilization by splint and compression | Device | Rigid splint with compression |
Primary outcome
Change in digital mobility of wounded finger
Time frame: 3 weeks, 6 weeks, 3 months, 6 months
Evaluation of digital mobility by measuring the palm-tip of the finger distance with a ruler. The active and passive mobility of the metacarpophalangeal, proximal and distal interphalangeal joints will be measured with a goniometer.
6 secondary outcomes
Change in pain
Time frame: 3 weeks, 6 weeks, 3 months, 6 months
Global function
Time frame: 3 months
Satisfaction
Time frame: 3 months
Cost
Time frame: six months
Change in strength
Time frame: 3 weeks, 6 weeks, 3 months, 6 months
Change in finger diameter
Time frame: 3 weeks, 6 weeks, 3 months, 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Finger Injuries
Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
Tendon Injuries
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syndactyly without compression, Syndactyly with compression and Rigid splint without compression in people with Finger Injuries, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Aug 2018. 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 Switzerland. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in digital mobility of wounded finger (time frame: 3 weeks, 6 weeks, 3 months, 6 months). 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 7 Aug 2018.