Clinical trial NCT04178655: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tendon Injury - Hand
Keywords: Tendon Injury, Tranexamic Acid
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Anatomic Result at 4-Months post-operatively
timeFrame: Documentation will take place pre-operatively, and 4-months post-operatively during out-patient clinic follow-up.
Secondary outcomes:
measure: Anatomic Result at 2-weeks and 8-weeks post-operatively
timeFrame: 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.
measure: Extent of finger and hand swelling
timeFrame: 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.
measure: Strength Result
timeFrame: 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.
measure: Functional Result - DASH Score
timeFrame: 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.
measure: Functional Result - PRWE Score
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References:
citation: Pulos N, Bozentka DJ. Management of complications of flexor tendon injuries. Hand Clin. 2015 May;31(2):293-9. doi: 10.1016/j.hcl.2014.12.004. Epub 2015 Feb 28.
citation: Legrand A, Kaufman Y, Long C, Fox PM. Molecular Biology of Flexor Tendon Healing in Relation to Reduction of Tendon Adhesions. J Hand Surg Am. 2017 Sep;42(9):722-726. doi: 10.1016/j.jhsa.2017.06.013. Epub 2017 Jul 12.
citation: Khanna A, Friel M, Gougoulias N, Longo UG, Maffulli N. Prevention of adhesions in surgery of the flexor tendons of the hand: what is the evidence? Br Med Bull. 2009;90:85-109. doi: 10.1093/bmb/ldp013. Epub 2009 Apr 24.
citation: Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005 Jan;87(1):187-202. doi: 10.2106/JBJS.D.01850.
citation: Ishiyama N, Moro T, Ohe T, Miura T, Ishihara K, Konno T, Ohyama T, Kimura M, Kyomoto M, Saito T, Nakamura K, Kawaguchi H. Reduction of Peritendinous adhesions by hydrogel containing biocompatible phospholipid polymer MPC for tendon repair. J Bone Joint Surg Am. 2011 Jan 19;93(2):142-9. doi: 10.2106/JBJS.I.01634.
citation: Murphy PG, Loitz BJ, Frank CB, Hart DA. Influence of exogenous growth factors on the synthesis and secretion of collagen types I and III by explants of normal and healing rabbit ligaments. Biochem Cell Biol. 1994 Sep-Oct;72(9-10):403-9. doi: 10.1139/o94-054.
citation: Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.
citation: Aguilera X, Martinez-Zapata MJ, Hinarejos P, Jordan M, Leal J, Gonzalez JC, Monllau JC, Celaya F, Rodriguez-Arias A, Fernandez JA, Pelfort X, Puig-Verdie Ll. Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial. Arch Orthop Trauma Surg. 2015 Jul;135(7):1017-25. doi: 10.1007/s00402-015-2232-8. Epub 2015 May 7.
citation: CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
citation: Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.
citation: McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray. Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
citation: Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.
citation: Oremus K, Sostaric S, Trkulja V, Haspl M. Influence of tranexamic acid on postoperative autologous blood retransfusion in primary total hip and knee arthroplasty: a randomized controlled trial. Transfusion. 2014 Jan;54(1):31-41. doi: 10.1111/trf.12224. Epub 2013 Apr 25.
citation: Frueh FS, Kunz VS, Gravestock IJ, Held L, Haefeli M, Giovanoli P, Calcagni M. Primary flexor tendon repair in zones 1 and 2: early passive mobilization versus controlled active motion. J Hand Surg Am. 2014 Jul;39(7):1344-50. doi: 10.1016/j.jhsa.2014.03.025. Epub 2014 May 5.
citation: Jansen CW, Watson MG. Measurement of range of motion of the finger after flexor tendon repair in zone II of the hand. J Hand Surg Am. 1993 May;18(3):411-7. doi: 10.1016/0363-5023(93)90083-f.
citation: Strickland JW, Glogovac SV. Digital function following flexor tendon repair in Zone II: A comparison of immobilization and controlled passive motion techniques. J Hand Surg Am. 1980 Nov;5(6):537-43. doi: 10.1016/s0363-5023(80)80101-8.
citation: Tang JB. Outcomes and evaluation of flexor tendon repair. Hand Clin. 2013 May;29(2):251-9. doi: 10.1016/j.hcl.2013.02.007.
citation: Elliot D, Harris SB. The assessment of flexor tendon function after primary tendon repair. Hand Clin. 2003 Aug;19(3):495-503. doi: 10.1016/s0749-0712(03)00028-3.
citation: MacDermid JC. Measurement of health outcomes following tendon and nerve repair. J Hand Ther. 2005 Apr-Jun;18(2):297-312. doi: 10.1197/j.jht.2005.02.009.
citation: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
citation: Hoang-Kim A, Pegreffi F, Moroni A, Ladd A. Measuring wrist and hand function: common scales and checklists. Injury. 2011 Mar;42(3):253-8. doi: 10.1016/j.injury.2010.11.050. Epub 2010 Dec 15.
citation: Libberecht K, Lafaire C, Van Hee R. Evaluation and functional assessment of flexor tendon repair in the hand. Acta Chir Belg. 2006 Sep-Oct;106(5):560-5. doi: 10.1080/00015458.2006.11679952.
citation: Dacombe PJ, Amirfeyz R, Davis T. Patient-Reported Outcome Measures for Hand and Wrist Trauma: Is There Sufficient Evidence of Reliability, Validity, and Responsiveness? Hand (N Y). 2016 Mar;11(1):11-21. doi: 10.1177/1558944715614855. Epub 2016 Jan 13.
citation: MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.