Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310570
Status:
UNKNOWN
Last Update Posted:
2006-04-04
First Post:
2006-04-02
Brief Title:
Comparison of Splinting Interventions for Treating Mallet Finger Injuries
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Comparison of Splinting Interventions for Minimising Extensor Lag in Mallet Finger Injuries
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stubbing of the finger-tip is a common injury in sports such as basketball volleyball cricket and football This can result in a Mallet finger deformity where the end joint of a finger cannot be actively straightened out In most mallet finger cases seen at The Alfred the skin remains intact and the impairment results from a tear of the extensor tendon or an avulsion a small fracture where the tendon attaches to the bone Treatment commonly involves immobilising the end joint of the finger in a splint for six or more weeks so patient compliance is a major factor in the quality of the outcome achieved
This study aims to compare two different types of splintage the commonly used thermoplastic thimble splint and the aluminium-foam Mexican hat splint which is in use in Britain with a control splint thermoplastic prefabricated stack splint with tape Outcome measures will include patient compliance with the splint degree of extensor lag active movement of the joint and any complications
The null hypothesis is that there are no differences in outcome between different methods of conservative splinting treatment for mallet finger
This study aims to compare two different types of splintage the commonly used thermoplastic thimble splint and the aluminium-foam Mexican hat splint which is in use in Britain with a control splint thermoplastic prefabricated stack splint with tape Outcome measures will include patient compliance with the splint degree of extensor lag active movement of the joint and any complications
The null hypothesis is that there are no differences in outcome between different methods of conservative splinting treatment for mallet finger
Detailed Description:
1 Literature Review
Mallet finger is defined as a loss of continuity of the distal insertion of the extensor tendon at the finger tip It is a common hand injury in ball sports McCue and Garroway 1985 but can also occur from minor incidents such as bed-making and tripsfalls Abouna and Brown 1968 The injury results in a drooping of the distal inter-phalangeal joint and is usually managed conservatively by splinting in hyper-extension for 6 or more weeks This position allows relaxation of the tendon and encourages healing by bringing the torn ends or fracture fragments closer together during the healing phase
A recent Cochrane Systematic review of the evidence in treating this injury Handoll and Vaghela 2005 found that there is insufficient evidence in existing randomised controlled trials to establish the effectiveness of different either custom-made or off-the-shelf finger splints for treating mallet finger injury They commented that there were only 4 trials that met the inclusion criteria and all of these were small heterogeneous inadequately described and reportedand had methodological flaws Evidence provided is therefore an inadequate base for clinical decision making
2 Rationale for project
If mallet injuries are not managed correctly the patient can be left with a persistent extension lag loss of voluntary straightening and swan neck deformity severe flexion deformity of distal finger joint plus a secondary hyperextension deformity of the proximal joint resulting from an imbalance in the extensor mechanism
Mallet injuries are relatively common with an estimated 100 cases treated at the Alfred last year and there is some debate about the best approach for their management The plastic surgery unit is keen to determine the optimal treatment for these injuries
The Cochrane systematic review Handoll and Vaghela 2005 found that there were only four relevant trials that met inclusion criteria and all of these had methodological flaws As this is a commonly presenting injury at The Alfred an opportunity exists to add to the evidence base by conducting a well-designed and thorough trial comparing the two most commonly advocated treatments with a suitable control
3 Hypothesisresearch questions
Null Hypothesis
There are no differences in outcome between different methods of conservative splinting treatment for mallet finger
4 Aims
To determine the most appropriate conservative treatment for mallet finger injuries
5 Methodology
We aim to conduct a randomised controlled trial of over 100 participants based on current referrals to hand therapy Subjects will be allocated to one of the following groups using a randomised computer sequence
Circumferential thermoplastic thimble splint or
dorsally applied aluminium-foam Mexican hat splint or
control splint off-the-shelf thermoplastic stack splint with tape NB it was considered unethical to provide a no treatment control given the amount of extension loss expected in an untreated injury and the likelihood of persistent finger deformity
All other aspects of treatment including frequency of contact duration of initial period of splintage and patient advice eg hygiene routine exercise splint donningdoffing will remain the same across all groups
Baseline data
age
gender
hand dominance
time since injury
type of injury bony versus soft-tissue
degree of extensor lag measured with a standardised goniometer
presence of other hand injuries on injured hand
smokernon-smoker
medication
hand dominance
occupation or hobbies
Progressive measurements to be taken at 6 8 10 12 and 20 weeks
degree of extensor lag measured with a standardised goniometer
development of complications and whether a change in splint type was required
patient adherence to treatment protocol based on self-report Patients will be provided with a simple diary to complete which records incidences of removal or adjustment of splint the reasons for this eg skin breakdown poor splint fit dislodged during activity and time out of splint
Outcome measures to be taken at 10 12 and 20 weeks
degree of extensor lag at the DIP
active range of motion at DIP
patient satisfaction with result on 5-point likert scale
pain measured by 10 point Visual Analogue Scale
Blinding of assessors
- all progressive and outcome measurements will be taken by a separate assessor not one of the current treating hand therapists trained in taking the measurements who has been blinded to the type of splint used To ensure this splints will be removed prior to the assessment and re-applied afterwards by the Allied Health Assistant using a standard donningdoffing technique
6 Inclusionexclusion criteria
All referrals of patients with mallet finger injuries will be considered for inclusion with the exception of the following exclusion criteria
open injuries where skin has been breached
mallet injury to thumb
co-existing rheumatologic illness
time from injury to presentation greater than 2 weeks
7 Randomisation procedures
Participants will be randomised to either of the 3 groups using a computer-generated randomised sequence
8 Statistical or other analyses
Sample size
We are aiming for 100 subjects but if referrals are low we have calculated statistical power for a total of 75 subjects
- With 25 subjects per group this study will have an 80 power to detect a difference in continuous variables equivalent to 80 of a standard deviation with a 2-sided p-value of 005 Based on the assumption of normality a reduction of one standard deviation would be equivalent to about 24 therefore a reduction of 8 of a standard deviation would be approximately equivalent to a 20 reduction A difference of this size is perceived to be of clinical importance Repeat measures analysis will further increase the power of this study although until between measures variability can be assessed it is unsure by how much
All data will be analysed using SAS version 82 SAS Institute Cary NC USA Data will be assessed for normality and log-transformed where appropriate Univariate analysis will be conducted using chi-square test for equal proportion analysis of variance and non-parametric Kruskal wallis tests where required Multivariate analysis will be performed using generalised linear modelling adjusting for potential covariates and repeat measures A two sided p-value of 005 will be considered to be statistically significant
Mallet finger is defined as a loss of continuity of the distal insertion of the extensor tendon at the finger tip It is a common hand injury in ball sports McCue and Garroway 1985 but can also occur from minor incidents such as bed-making and tripsfalls Abouna and Brown 1968 The injury results in a drooping of the distal inter-phalangeal joint and is usually managed conservatively by splinting in hyper-extension for 6 or more weeks This position allows relaxation of the tendon and encourages healing by bringing the torn ends or fracture fragments closer together during the healing phase
A recent Cochrane Systematic review of the evidence in treating this injury Handoll and Vaghela 2005 found that there is insufficient evidence in existing randomised controlled trials to establish the effectiveness of different either custom-made or off-the-shelf finger splints for treating mallet finger injury They commented that there were only 4 trials that met the inclusion criteria and all of these were small heterogeneous inadequately described and reportedand had methodological flaws Evidence provided is therefore an inadequate base for clinical decision making
2 Rationale for project
If mallet injuries are not managed correctly the patient can be left with a persistent extension lag loss of voluntary straightening and swan neck deformity severe flexion deformity of distal finger joint plus a secondary hyperextension deformity of the proximal joint resulting from an imbalance in the extensor mechanism
Mallet injuries are relatively common with an estimated 100 cases treated at the Alfred last year and there is some debate about the best approach for their management The plastic surgery unit is keen to determine the optimal treatment for these injuries
The Cochrane systematic review Handoll and Vaghela 2005 found that there were only four relevant trials that met inclusion criteria and all of these had methodological flaws As this is a commonly presenting injury at The Alfred an opportunity exists to add to the evidence base by conducting a well-designed and thorough trial comparing the two most commonly advocated treatments with a suitable control
3 Hypothesisresearch questions
Null Hypothesis
There are no differences in outcome between different methods of conservative splinting treatment for mallet finger
4 Aims
To determine the most appropriate conservative treatment for mallet finger injuries
5 Methodology
We aim to conduct a randomised controlled trial of over 100 participants based on current referrals to hand therapy Subjects will be allocated to one of the following groups using a randomised computer sequence
Circumferential thermoplastic thimble splint or
dorsally applied aluminium-foam Mexican hat splint or
control splint off-the-shelf thermoplastic stack splint with tape NB it was considered unethical to provide a no treatment control given the amount of extension loss expected in an untreated injury and the likelihood of persistent finger deformity
All other aspects of treatment including frequency of contact duration of initial period of splintage and patient advice eg hygiene routine exercise splint donningdoffing will remain the same across all groups
Baseline data
age
gender
hand dominance
time since injury
type of injury bony versus soft-tissue
degree of extensor lag measured with a standardised goniometer
presence of other hand injuries on injured hand
smokernon-smoker
medication
hand dominance
occupation or hobbies
Progressive measurements to be taken at 6 8 10 12 and 20 weeks
degree of extensor lag measured with a standardised goniometer
development of complications and whether a change in splint type was required
patient adherence to treatment protocol based on self-report Patients will be provided with a simple diary to complete which records incidences of removal or adjustment of splint the reasons for this eg skin breakdown poor splint fit dislodged during activity and time out of splint
Outcome measures to be taken at 10 12 and 20 weeks
degree of extensor lag at the DIP
active range of motion at DIP
patient satisfaction with result on 5-point likert scale
pain measured by 10 point Visual Analogue Scale
Blinding of assessors
- all progressive and outcome measurements will be taken by a separate assessor not one of the current treating hand therapists trained in taking the measurements who has been blinded to the type of splint used To ensure this splints will be removed prior to the assessment and re-applied afterwards by the Allied Health Assistant using a standard donningdoffing technique
6 Inclusionexclusion criteria
All referrals of patients with mallet finger injuries will be considered for inclusion with the exception of the following exclusion criteria
open injuries where skin has been breached
mallet injury to thumb
co-existing rheumatologic illness
time from injury to presentation greater than 2 weeks
7 Randomisation procedures
Participants will be randomised to either of the 3 groups using a computer-generated randomised sequence
8 Statistical or other analyses
Sample size
We are aiming for 100 subjects but if referrals are low we have calculated statistical power for a total of 75 subjects
- With 25 subjects per group this study will have an 80 power to detect a difference in continuous variables equivalent to 80 of a standard deviation with a 2-sided p-value of 005 Based on the assumption of normality a reduction of one standard deviation would be equivalent to about 24 therefore a reduction of 8 of a standard deviation would be approximately equivalent to a 20 reduction A difference of this size is perceived to be of clinical importance Repeat measures analysis will further increase the power of this study although until between measures variability can be assessed it is unsure by how much
All data will be analysed using SAS version 82 SAS Institute Cary NC USA Data will be assessed for normality and log-transformed where appropriate Univariate analysis will be conducted using chi-square test for equal proportion analysis of variance and non-parametric Kruskal wallis tests where required Multivariate analysis will be performed using generalised linear modelling adjusting for potential covariates and repeat measures A two sided p-value of 005 will be considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None