AmputationNCT03383640
Early Active Finger Exercises in Replanted Fingers
A study testing Active exercises in people with Amputation, run by Oslo University Hospital.
Trial summary
A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Active exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 5 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Total or subtotal amputation injury of 1-4 of the four ulnar digits
- Injury distal to the MCP joint
- Must have injured flexor tendon which requires suture
- Must have a fracture
- Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
- The finger must have had a stable circulation for at least 5 days post-surgery
Who cannot join
- Arthrodesis/temporary fixation of the MCP joint
- Bilateral amputation injury
- Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
- Patients who cannot follow the planned controls
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Will Early Active Finger Exercises in Replanted Fingers Improve Mobility? A Prospective Randomized Trial
A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.
- Conditions
- Amputation
- Being tested
- Active exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active exercisesOther
Active flexion movements every waking hour of the replanted digits
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone. |
| Intervention | Other | Intervention Group: Early active exercises of the replanted digits started between day 5 and 7 after surgery, as instructed by hand therapist Receives: Other: Active exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAM
Total active movement of the interphalangeal joints
Measured: 12 months
Secondary outcomes (5)
Quick-DASH
Upper extremity function score (patient related outcome measure)
Measured: 12 months
VAS Pain
Visual Analogue Score Pain
Measured: 12 months
VAS Function
Visual Analogue Score Function
Measured: 12 months
Grip strength
Jamar dynanometer
Measured: 12 months
Key pinch
Jamar dynamometer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion5 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanne Korslund, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383640
- Sponsor's protocol ID
- 2017/1282 D
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Early Active Finger Exercises in Replanted Fingers Improve Mobility? A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03383640
- Acronym / sponsor ID
- 2017/1282 D
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 5 Jan 2021 (estimated)
- First posted
- 26 Dec 2017 (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.
A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone. |
| Intervention | Other | Other: Active exercisesIntervention Group: Early active exercises of the replanted digits started between day 5 and 7 after surgery, as instructed by hand therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 18 years
- Total or subtotal amputation injury of 1-4 of the four ulnar digits
- Injury distal to the MCP joint
- Must have injured flexor tendon which requires suture
- Must have a fracture
Key exclusion criteria (4 listed)
- Arthrodesis/temporary fixation of the MCP joint
- Bilateral amputation injury
- Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
- Patients who cannot follow the planned controls
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 |
|---|---|---|
| Active exercisesActive flexion movements every waking hour of the replanted digits | Other | Intervention |
Primary outcome
TAM
Time frame: 12 months
Total active movement of the interphalangeal joints
5 secondary outcomes
Quick-DASH
Time frame: 12 months
VAS Pain
Time frame: 12 months
VAS Function
Time frame: 12 months
Grip strength
Time frame: 12 months
Key pinch
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Active exercises in people with Amputation, run by Oslo University Hospital.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanne Korslund, Cand.med (004795961393, johanne.korslund@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAM (time frame: 12 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 26 Dec 2017.