Conservatively Treated Mallet Finger InjuryNCT04830917
Conservative Treatment of Mallet Finger Injury
A study testing Immobilization type for mallet injury in people with Conservatively Treated Mallet Finger Injury, run by Orthopaedic Specialty Group PC, Fairfield at 1 site in United States.
Trial summary
Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conservatively Treated Mallet Finger Injury
- What is being tested?
- Immobilization type for mallet injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 28 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age
Who cannot join
- previous injury to the involved digit impacting ROM
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Specialty Group PC
Fairfield, Connecticut, 06825
About this study
Official title: Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.
- Being tested
- Immobilization type for mallet injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immobilization type for mallet injuryOther
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Kinesiotape and Oval 8 | Experimental | Not described Receives: Other: Immobilization type for mallet injury |
| Treatment with quick cast | Experimental | Not described Receives: Other: Immobilization type for mallet injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Measured: 12 weeks from injury
Secondary outcomes (9)
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Measured: 6 months post injury
Brief Michigan Hand Outcome Questionnaire
Measured: 12 weeks from injury
Brief Michigan Hand Outcome Questionnaire
Measured: 6 months post injury
Satisfaction on a visual analog scale (0-10)
Measured: 12 weeks from injury
Satisfaction on a visual analog scale (0-10)
Measured: 6 months post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Measured: 12 week post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Measured: 6 months post injury
Pain according to a numeric pain rating scale (0-10/10)
Measured: 12 weeks after injury
Pain according to a numeric pain rating scale (0-10/10)
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start24 Apr 2017
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conservatively Treated Mallet Finger InjuryStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Specialty Group PC, Fairfield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Algar, Orthopaedic Specialty Group PC, Fairfield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830917
- Sponsor's protocol ID
- SVMC 17-328
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
- ClinicalTrials.gov ID
- NCT04830917
- Acronym / sponsor ID
- SVMC 17-328
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Orthopaedic Specialty Group PC, FairfieldUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 5 Apr 2021 (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.
Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Kinesiotape and Oval 8 | Experimental | Other: Immobilization type for mallet injury |
| Treatment with quick cast | Experimental | Other: Immobilization type for mallet injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age
Key exclusion criteria (1 listed)
- previous injury to the involved digit impacting ROM
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 |
|---|---|---|
| Immobilization type for mallet injuryMethod to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury | Other | Treatment with Kinesiotape and Oval 8, Treatment with quick cast |
Primary outcome
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time frame: 12 weeks from injury
9 secondary outcomes
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time frame: 6 months post injury
Brief Michigan Hand Outcome Questionnaire
Time frame: 12 weeks from injury
Brief Michigan Hand Outcome Questionnaire
Time frame: 6 months post injury
Satisfaction on a visual analog scale (0-10)
Time frame: 12 weeks from injury
Satisfaction on a visual analog scale (0-10)
Time frame: 6 months post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time frame: 12 week post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time frame: 6 months post injury
Pain according to a numeric pain rating scale (0-10/10)
Time frame: 12 weeks after injury
Pain according to a numeric pain rating scale (0-10/10)
Time frame: 6 months post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided
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 Immobilization type for mallet injury in people with Conservatively Treated Mallet Finger Injury, run by Orthopaedic Specialty Group PC, Fairfield at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 21 Apr 2022. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit (time frame: 12 weeks from injury). 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 21 Apr 2022.