Tranexamic Acid Effect on Digit Function Following Primary Repair of Traumatic Digit Flexor Tendon Injuries

November 24, 2019 updated by: Sorin Daniel Iordache, Rabin Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. Study Group - Intra-venous Tranexamic acid treatment
  2. 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

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid Treatment
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Drug: Tranexamic acid injection
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Placebo Comparator: Placebo
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Drug: PLACEBO
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic Result at 4-Months post-operatively
Time Frame: Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up.

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.
Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic Result at 2-weeks and 8-weeks post-operatively
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.

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.
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.
Extent of finger and hand swelling
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.

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.
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.
Strength Result
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.

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.
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.
Functional Result - DASH Score
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.

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).
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.
Functional Result - PRWE Score
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.

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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

November 24, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0219-19-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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