Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
Primary Purpose
Tendon Injury - Hand
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic acid injection
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Tendon Injury - Hand focused on measuring Tendon Injury, Tranexamic Acid
Eligibility Criteria
Inclusion Criteria:
- Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
Exclusion Criteria:
- Age < 18
- Pregnant Women
- Patients that presented 3 weeks or later after the injury
- Medical history positive for Rheumatic disease
- Current active treatment with anti-coagulation medications
- Injury to more than one finger
- Presence of a fracture in the affected finger
- Presence of a nerve injury in the affected finger that won't enable early use and activation in early rehabilitation protocol
- Mangled extremity injury, degloving injury or other soft tissue injuries that won't enable primary closure of skin
- Previous tear of the affected tendon
- Degenerative tear of flexor tendon
- Tendon tear secondary to infection
- Previous injuries to contralateral side causing dysfunction and/or decreased fingers' range of motion
Contraindications to Tranexamic acid treatment:
- Known hypersensitivity to tranexamic acid or to any other ingredient of the preparation.
- Patients with thromboembolic disease.
- Patients with active intravascular clotting.
- Severe renal failure because of risk of accumulation.
- Patients with subarachnoid hemorrhage
- Patients with acquired defective color vision
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid Treatment
Placebo
Arm Description
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Outcomes
Primary Outcome Measures
Anatomic Result at 4-Months post-operatively
Measurement of the anatomical outcome for both Zone1 and Zone 2 tears will be achieved by measuring the Total Active Motion (TAM) using the American Society for Surgery of the Hand Criteria (ASSH).
Active flexion of the MCPJ, PIP and DIP joints are measured in degrees, and summed. Extension deficits in these joints are measured in degrees, summed, and deducted from the flexion measurements. The full TAM of a finger is 260 degrees: MCPJ 85 degrees, PIPJ 110 degrees and DIPJ 65 degrees The TAM of the affected side can be compared to the normal contralateral side, and expressed as percentage of return of motion.
The Change of the TAM from baseline will be recorded for at the planned serial follow-ups, as described below.
Secondary Outcome Measures
Anatomic Result at 2-weeks and 8-weeks post-operatively
Measurement of the anatomical outcome for both Zone1 and Zone 2 tears will be achieved by measuring the Total Active Motion (TAM) using the American Society for Surgery of the Hand Criteria (ASSH).
Active flexion of the MCPJ, PIP and DIP joints are measured in degrees, and summed. Extension deficits in these joints are measured in degrees, summed, and deducted from the flexion measurements. The full TAM of a finger is 260 degrees: MCPJ 85 degrees, PIPJ 110 degrees and DIPJ 65 degrees The TAM of the affected side can be compared to the normal contralateral side, and expressed as percentage of return of motion.
The Change of the TAM from baseline to each post-operative follow up will be recorded.
Extent of finger and hand swelling
Estimation of finger and hand swelling will be achieved by calculating a Swelling-Ratio (SR). Direct measurement of the circumference of both the affected and unaffected finger and hand palm will be made. Finger circumference will be measured in two anatomic locations: the middle of both the proximal and middle phalanx. Hand circumference will be measured on the level of the distal palmar crease. Above measurements will be documented in centimeters.
The SR will be calculated by dividing the circumference of the affected side by the circumference of the unaffected side.
Strength Result
Grip Strength is a widely-used clinical assessment tool , which gives a good global assessment of muscle strength, and delineates the impact of tendon injury on overall strength.
After flexor tendon repair, impairments are more common in isolated finger flexion than in overall handgrip strength. overall grip strength is the mainstay of strength assessment.
There are several standardized protocols to assess grip strength, one is performing the measurement with the elbow flexed 90 degrees, the forearm in neutral, and the Patient gripping the Jamar dynamometer at the second handle position. Estimation of hand grip strength will be achieved by calculating a Grip Strength-Ratio (GSR). Direct measurement of the Grip strength of both the affected and unaffected hands will be made. Above measurements will be documented in kilograms.
The GSR will be calculated by dividing the grip strength of the affected hand by the grip strength of the unaffected side.
Functional Result - DASH Score
Functional Evaluation will be achieved using the DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire.
The DASH Score is the current most practiced scale for upper extremity functionality, and was extensively validated in numerous studies.
The Scale ranges from 0 (no disability) to 100 (most severe disability).
Functional Result - PRWE Score
Functional Evaluation will be achieved using the PRWE (Patient-Rated Wrist Evaluation) Questionnaire.
The PRWE was originally developed in 1998 as a measure of patient-rated pain and disability, following Distal Radius or Scaphoid Fractures.
The Scale ranges from 0 (no disability) to 100 (most severe disability).
Full Information
NCT ID
NCT04178655
First Posted
November 1, 2019
Last Updated
November 24, 2019
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04178655
Brief Title
Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
Official Title
Range of Motion and Function Following Primary Repair of Traumatic Zone 1 or Zone 2 Digit Flexor Tendon Injuries - Impact of Tranexamic Acid Use - A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study evaluates the effect of pre-operative treatment with IV Tranexamic Acid on post-operative digit function, in patients that underwent surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tear.
Detailed Description
Peritendinous adhesions following repair of digital flexor tendons are a major postoperative complication, due to loss of motion and the functional disability that they cause.
Patients who will present to Rabin Medical Center with acute traumatic Zone 1 or Zone 2 Digit flexor tendon injury, will be recruited to the study, given the patients' informed consent.
Patients recruited to the study will be randomly assigned to either the study group or control group:
Study Group - Intra-venous Tranexamic acid treatment
Control Group - Placebo (Intra-venous normal saline 0.9%)
All patients will be treated operatively with primary repair of the lacerated flexor tendon.
All patients will be treated post-operatively with early controlled mobilization according to the Duran Protocol.
Randomization of the patients will take place before surgery, in the following manner:
half of the study population will be treated with IV Tranexamic Acid , the other half will be treated with or IV Normal Saline as Placebo.
Either Tranexamic Acid or IV Normal Saline will be administered by the anesthesiologist present in the operating room, prior to tourniquet inflation.
Each patient will be assigned a serial number, and 2 envelopes allocated to that serial number will be prepared in advance. The first envelope will be attached to the patient's file, and be given only to the anesthesiologist in the operating room. The second envelope assigned to the patient will remain closed until the end of the study, along with the study's documents.
All study patients and hand surgeons will be blinded to the treatment received by the study population.
Post-Operative measurements will be made by an orthopedic surgeon or occupational therapist, which will also be blinded to the treatment received by the study population.
To ensure confidentiality, all study documents and data will be kept inside a locked closet, in a locked room in the orthopedic department
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injury - Hand
Keywords
Tendon Injury, Tranexamic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid Treatment
Arm Type
Experimental
Arm Description
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Primary Outcome Measure Information:
Title
Anatomic Result at 4-Months post-operatively
Description
Measurement of the anatomical outcome for both Zone1 and Zone 2 tears will be achieved by measuring the Total Active Motion (TAM) using the American Society for Surgery of the Hand Criteria (ASSH).
Active flexion of the MCPJ, PIP and DIP joints are measured in degrees, and summed. Extension deficits in these joints are measured in degrees, summed, and deducted from the flexion measurements. The full TAM of a finger is 260 degrees: MCPJ 85 degrees, PIPJ 110 degrees and DIPJ 65 degrees The TAM of the affected side can be compared to the normal contralateral side, and expressed as percentage of return of motion.
The Change of the TAM from baseline will be recorded for at the planned serial follow-ups, as described below.
Time Frame
Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up.
Secondary Outcome Measure Information:
Title
Anatomic Result at 2-weeks and 8-weeks post-operatively
Description
Measurement of the anatomical outcome for both Zone1 and Zone 2 tears will be achieved by measuring the Total Active Motion (TAM) using the American Society for Surgery of the Hand Criteria (ASSH).
Active flexion of the MCPJ, PIP and DIP joints are measured in degrees, and summed. Extension deficits in these joints are measured in degrees, summed, and deducted from the flexion measurements. The full TAM of a finger is 260 degrees: MCPJ 85 degrees, PIPJ 110 degrees and DIPJ 65 degrees The TAM of the affected side can be compared to the normal contralateral side, and expressed as percentage of return of motion.
The Change of the TAM from baseline to each post-operative follow up will be recorded.
Time Frame
Serial documentation will take place pre-operatively, and post-operatively during out-patient clinic follow-ups on a planned basis at 2-weeks and 8-weeks post-operatively.
Title
Extent of finger and hand swelling
Description
Estimation of finger and hand swelling will be achieved by calculating a Swelling-Ratio (SR). Direct measurement of the circumference of both the affected and unaffected finger and hand palm will be made. Finger circumference will be measured in two anatomic locations: the middle of both the proximal and middle phalanx. Hand circumference will be measured on the level of the distal palmar crease. Above measurements will be documented in centimeters.
The SR will be calculated by dividing the circumference of the affected side by the circumference of the unaffected side.
Time Frame
Serial documentation will take place pre-operatively, and post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.
Title
Strength Result
Description
Grip Strength is a widely-used clinical assessment tool , which gives a good global assessment of muscle strength, and delineates the impact of tendon injury on overall strength.
After flexor tendon repair, impairments are more common in isolated finger flexion than in overall handgrip strength. overall grip strength is the mainstay of strength assessment.
There are several standardized protocols to assess grip strength, one is performing the measurement with the elbow flexed 90 degrees, the forearm in neutral, and the Patient gripping the Jamar dynamometer at the second handle position. Estimation of hand grip strength will be achieved by calculating a Grip Strength-Ratio (GSR). Direct measurement of the Grip strength of both the affected and unaffected hands will be made. Above measurements will be documented in kilograms.
The GSR will be calculated by dividing the grip strength of the affected hand by the grip strength of the unaffected side.
Time Frame
Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.
Title
Functional Result - DASH Score
Description
Functional Evaluation will be achieved using the DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire.
The DASH Score is the current most practiced scale for upper extremity functionality, and was extensively validated in numerous studies.
The Scale ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.
Title
Functional Result - PRWE Score
Description
Functional Evaluation will be achieved using the PRWE (Patient-Rated Wrist Evaluation) Questionnaire.
The PRWE was originally developed in 1998 as a measure of patient-rated pain and disability, following Distal Radius or Scaphoid Fractures.
The Scale ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Serial documentation will take place post-operatively during out-patient clinic follow-ups on a planned basis: 2-weeks, 8-weeks, and 4-months post-operatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
Exclusion Criteria:
Age < 18
Pregnant Women
Patients that presented 3 weeks or later after the injury
Medical history positive for Rheumatic disease
Current active treatment with anti-coagulation medications
Injury to more than one finger
Presence of a fracture in the affected finger
Presence of a nerve injury in the affected finger that won't enable early use and activation in early rehabilitation protocol
Mangled extremity injury, degloving injury or other soft tissue injuries that won't enable primary closure of skin
Previous tear of the affected tendon
Degenerative tear of flexor tendon
Tendon tear secondary to infection
Previous injuries to contralateral side causing dysfunction and/or decreased fingers' range of motion
Contraindications to Tranexamic acid treatment:
Known hypersensitivity to tranexamic acid or to any other ingredient of the preparation.
Patients with thromboembolic disease.
Patients with active intravascular clotting.
Severe renal failure because of risk of accumulation.
Patients with subarachnoid hemorrhage
Patients with acquired defective color vision
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data will be made available
IPD Sharing Time Frame
within 6 months of study completion
IPD Sharing Access Criteria
requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
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Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries
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