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Trial registered on ANZCTR


Registration number
ACTRN12618000019202
Ethics application status
Approved
Date submitted
8/11/2017
Date registered
11/01/2018
Date last updated
9/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial for the assessment of effect of oral ibuprofen drug on the outcome post repair of hand flexor tendons
Scientific title
A double blind randomised controlled trial assessing the effect of oral ibuprofen on outcome of flexor tendon repairs
Secondary ID [1] 293286 0
NIL
Universal Trial Number (UTN)
U1111-1204-7715
Trial acronym
IFTT (Ibuprofen Flexor Tendon Trial)
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Hand flexor tendon injury 305390 0
Condition category
Condition code
Musculoskeletal 304676 304676 0 0
Other muscular and skeletal disorders
Injuries and Accidents 304722 304722 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral ibuprofen 400 mg three times a day for three weeks post flexor tendon repair in interventional arm
Intervention code [1] 299567 0
Treatment: Drugs
Comparator / control treatment
Control arm (paracetamol) will receive 1000 mg paracetamol three times a day for three weeks as a pain killer and will act as a active control.
(It is considered a active control group as paracetamol has minimal anti-inflammatory activity and is used as centrally acting anti-pyretic and pain killer. Ibuprofen will be beneficial due to local anti-inflammatory activity through enzyme inhibition.)
Control group
Active

Outcomes
Primary outcome [1] 303893 0
Range of motion assessment using Strickland criteria for PIPJ and DIPJ with contralateral hand as normal. If contralateral hand is not normal, 175 degrees ROM for both joints is considered the normal value. The sum of the degrees of active PIPJ and DIPJ flexion less the degrees from full extension is taken as motion range. Function Grade assessment is reported as: Excellent 85-100%, Good 70-84%, Fair 50-69%, Poor <50% (expressed in percentage of normal).
Timepoint [1] 303893 0
6 weeks and 12 weeks (primary endpoint) after flexor tendon repair
Primary outcome [2] 303927 0
Total Active Motion under this criteria is calculated in a similar manner as the range of motion under Strickland criteria, but also includes the MCPJ range of motion: Active Range of Motion (AROM) from MCPJ, PIPJ and DIPJ with contralateral as normal, if contralateral hand is normal. If contralateral hand is not normal, 260 degrees TAM for all three joints is considered the normal value. The sum of the degrees of active MCPJ, PIPJ and DIPJ flexion less the degrees from full extension is taken as motion range. Function grade assessment is reported as: Excellent 100%, Good >75%, fair >50%, Poor <50% (expressed in percentage of normal).
Timepoint [2] 303927 0
6 and 12 weeks (primary endpoint) after flexor tendon repair
Primary outcome [3] 303928 0
3) Grip Strength assessment: Grip strength will recorded using hand dynamo-meter as percentage of the contra-lateral hand grip strength.
Timepoint [3] 303928 0
6 and 12 weeks (primary endpoint) after flexor tendon repair
Secondary outcome [1] 340372 0
This is a primary outcome no. 4:

4) Michigan Hand Outcomes Questionnaire for evaluation of hand outcome for each hand separately.
Timepoint [1] 340372 0
6 weeks and 12 weeks (primary endpoint) after flexor tendon repair
Secondary outcome [2] 340478 0
Secondary outcome 1: Finger circumference of the finger with repaired tendon at PIPJ will be taken and compared with contra-lateral hand at each visit using a string and will be recorded in millimetres.
Timepoint [2] 340478 0
6 and 12 weeks after flexor tendon repair
Secondary outcome [3] 340684 0
Secondary outcome 2:

Patients will also be assessed and followed up for delayed wound healing. Surgical incisions will be evaluated for complete epithelisation without any remaining wound.
Timepoint [3] 340684 0
6 and 12 weeks after flexor tendon repair
Secondary outcome [4] 340685 0
Secondary outcome 3:

Patients will also be assessed and followed up for rupture of tendons. Any clinical complete loss of function for a particular hand flexor tendon will be noted as a sign of rupture of repaired tendon.
Timepoint [4] 340685 0
6 and 12 weeks after flexor tendon repair
Secondary outcome [5] 340686 0
Secondary outcome 4:

Patients will also be assessed and followed up for the need for tenolysis or follow up surgeries. Any decreased range of motion for joints that is severe enough to hamper activities of daily living or work will be an indication for further surgery including tenolysis.
Timepoint [5] 340686 0
6 and 12 weeks after flexor tendon repair

Eligibility
Key inclusion criteria
Adults (aged 18 years and above) undergoing repair with acute (less than 14 days) sharp laceration to single or multiple fingers flexor tendon injury – flexor digitorum superficialis (FDS) / flexor digitorum profundus (FDP) or both, with or without neurovascular injury.

Able to participate in early active therapy protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking patients.
Patients who do not wish or are unable to follow the protocol (intellectual impairment)
Crush or avulsion injuries.
Replantation or revascularization procedures (both neurovascular bundles damaged with pre-operative vascular compromise) (as this will change the rehabilitation)
Polytrauma patients (that would affect the ability to undertake appropriate hand therapy).
Previous hand injury or arthritis with pre-existing hand stiffness, which limited hand range of motion
Patients on warfarin or similar anticoagulants and patients already on NSAIDs or paracetamol containing medications.
Pregnant or breastfeeding females
Contraindications to ibuprofen or paracetamol use including:
Hypersensitivity or allergy to ibuprofen , paracetamol or other NSAIDs ex. aspirin -induced asthma
Liver or renal impairment, heart failure, diabetes or malignancy
Asthmatics without any prior history of NSAIDs intake
History of peptic ulcer or gastric bleeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using serial numbers and opaque envelopes/containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The ralloc command of the Stata statistical program will be used to create a Block Randomisation. The randomisation list (Participant Number, Ibuprofen or Paracetamol) will be forwarded to the Pharmacy where the appropriate drug sufficient for 3 weeks use will be packaged along with dosing instructions and the packages labeled with the name of the trial and the Participant Number. Participants will be provided with consecutive Participant Numbers upon consent.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We expect to achieve 85% of normal range of motion for the finger joints in intervention arm at the end of 12 weeks. We hypothesize that finger movement in the ibuprofen group will be better than the control arm. In the clinical setting, this means a difference of about 35 degrees of the total movement of the finger. The number has been derived from prior studies where a difference of 35 degrees moves a patient from the good to the excellent category.

This study is designed to detect a difference of 35 degrees in the PIPJ+DIPJ ROM between control arm and ibuprofen (interventional) arm where the mean angle of control arm is 114 degrees and the ibuprofen arm is 149 degrees. The difference is considered the smallest clinically relevant difference. Based on using a two-sample t-test with a SD of 45 in each group, for a type 1 error (alpha) of 0.05 and a power of 90% we will require a total of 60 participants, 30 in each arm. Considering 10% withdrawal rate, sample size will be kept at 66 participants, 33 in each arm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
4/05/2018
Date of last participant enrolment
Anticipated
1/02/2019
Actual
Date of last data collection
Anticipated
1/05/2019
Actual
Sample size
Target
66
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9359 0
Gold Coast Hospital - Southport
Recruitment hospital [2] 9360 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 18048 0
4215 - Southport
Recruitment postcode(s) [2] 18049 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 297911 0
Hospital
Name [1] 297911 0
Gold Coast Hospital and Health Service
Country [1] 297911 0
Australia
Funding source category [2] 298589 0
Government body
Name [2] 298589 0
Private Practice Trust Fund
Country [2] 298589 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Gold Coast Hospital and Health Service, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 296971 0
Individual
Name [1] 296971 0
Professor Randy Bindra
Address [1] 296971 0
Professor Randy Bindra, Clinical Administration, Block A, Level 6, Gold Coast University Hospital, 1 Hospital Boulevard, Southport, QLD 4215
Country [1] 296971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298961 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 298961 0
Research Directorate
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 298961 0
Australia
Date submitted for ethics approval [1] 298961 0
15/11/2017
Approval date [1] 298961 0
24/01/2018
Ethics approval number [1] 298961 0
HREC/17/QGC/322

Summary
Brief summary
Title: A double blind randomised controlled trial assessing the effect of oral ibuprofen on outcome of flexor tendon repairs

Short Title: Ibuprofen Flexor Tendon Trial (IFTT)

Design: Double Blind Randomised Controlled Trial

Hospital/s: Gold Coast Hospital and Health Service

Study Question: Does oral ibuprofen influence outcome in patients post flexor tendon repair?

Primary purpose of the study: This study has been designed to assess the effect of using oral ibuprofen after repair of hand flexor tendons on function and final outcome of hand . Study hypothesis is that use of oral ibuprofen after flexor tendon repair will result in improved outcome in comparison to when ibuprofen is not given.Ibuprofen should also result in decreased swelling of fingers.

Many work hours will be saved and quality of life will be improved in flexor tendon repair patients if the study hypothesis is found to be true and a cheap and easily available drug like ibuprofen can reduce financial burden of these injuries on society and community.

Study Objectives:

Primary Objectives:

Assessment of the effect of oral ibuprofen on outcome of flexor tendon repairs in humans:

1) Range of motion assessment using Strickland criteria
2) Range of motion assessment using ASSH criteria
3) Grip strength assessment
4) Michigan Hand Outcomes Questionnaire for evaluation of hand outcome

Secondary Objectives:

1) Assessment of finger circumference
2)Assessment for delayed wound healing
3) Assessment for rupture of tendons
4) Assessment of need for tenolysis or follow up surgeries.


Inclusion Criteria:
18 years of age and above

Exclusion Criteria:
Contraindication to NSAIDs/ibuprofen, systemic conditions/diseases like cardiac, renal, CNS, GI and others, documented allergy to NSAIDs

Number of Planned Subjects:
66

Investigational product:
Oral Ibuprofen

Safety considerations:
Coexisting cardiovascular, gastrointestinal and renal diseases; certain drugs

Statistical Methods:
Two arm trial- interventional and control. Two-sample t-test for a type 1 error (alpha) of 0.05 and a power of 90% for sample size calculation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2413 2413 0 0
/AnzctrAttachments/373936-Ver 4 PI and consent sheet Jan 2017.pdf (Participant information/consent)
Attachments [2] 2414 2414 0 0
/AnzctrAttachments/373936-HREC 17 QGC 322_Ethics Approval.pdf (Ethics approval)
Attachments [3] 2678 2678 0 0
/AnzctrAttachments/373936-HREC17QGC322 Amendment Approval AM01 20180424.pdf (Other)
Attachments [4] 2679 2679 0 0
/AnzctrAttachments/373936(v08-05-2018-19-13-30)-Ver 5 Protocol NSAIDs final, Apr 2018.pdf (Protocol)

Contacts
Principal investigator
Name 78802 0
Prof Randy Bindra
Address 78802 0
Clinical Administration, A Block, Level 6, Gold Coast University Hospital, Hospital Boulevard, Southport, QLD 4215
Country 78802 0
Australia
Phone 78802 0
+61 (0)421595857
Fax 78802 0
Email 78802 0
[email protected]
Contact person for public queries
Name 78803 0
Prof Randy Bindra
Address 78803 0
Clinical Administration, A Block, Level 6, Gold Coast University Hospital, Hospital Boulevard, Southport, QLD 4215
Country 78803 0
Australia
Phone 78803 0
+61 (0)421595857
Fax 78803 0
Email 78803 0
[email protected]
Contact person for scientific queries
Name 78804 0
Prof Randy Bindra
Address 78804 0
Clinical Administration, A Block, Level 6, Gold Coast University Hospital, Hospital Boulevard, Southport, QLD 4215
Country 78804 0
Australia
Phone 78804 0
+61 (0)421595857
Fax 78804 0
Email 78804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.