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

Early Phase 1

• Conditions: Tendon Injury - Hand
• Interventions: Drug: Tranexamic acid injection; Drug: PLACEBO

• Registration Number: NCT04178655
• Lead Sponsor: Rabin Medical Center

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:

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 Timeline

• Status Verified: 2019-11
• Study Start: 2019-11
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-24
• Last Update Submitted: 2019-11-24
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26
• Primary Completion: 2022-11
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid Treatment	Tranexamic acid injection	1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
Placebo	PLACEBO	10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION

Primary Outcome Measures

Name	Time	Method
Anatomic Result at 4-Months post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Strength Result	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.
Functional Result - PRWE Score	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).
Anatomic Result at 2-weeks and 8-weeks post-operatively	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.
Extent of finger and hand swelling	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.
Functional Result - DASH Score	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).