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
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 48
- 主要终点
- Anatomic Result at 4-Months post-operatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that will undergo surgical repair of traumatic zone 1 or zone 2 digit flexor tendon tears
排除标准
- •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
研究组 & 干预措施
Placebo
10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
干预措施: PLACEBO (Drug)
Tranexamic Acid Treatment
1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Anatomic Result at 4-Months post-operatively
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Sorin Daniel Iordache
Hand Surgery Unit Director, Rabin Medical Center
Rabin Medical Center