Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06280456 |
| Other study ID # |
2023-09-017A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 5, 2022 |
| Est. completion date |
February 5, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Taipei Veterans General Hospital, Taiwan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Post-anterior cruciate ligament reconstruction (ACLR) hemarthrosis may result in increased
pain thus delaying postoperative rehabilitation, which may eventually lead to arthrofibrosis
and a functional deficit. Many antifibrinolytic agents, including tranexamic acid (TXA), have
been used in orthopedic surgeries to reduce postoperative bleeding. Moreover, TXA was proved
effective to reduced the events of hemarthrosis and increased the post-operative functional
outcomes of the patients in several studies. The purpose of this study is to evaluate the
efficacy of intra-articular injection of TXA with different drainage clamping time in
patients receiving arthroscopic ACLRs. Patients were randomized into four groups. An
intra-articular suction drain was placed recorded 24 h postoperatively. Group 1 patients(TXA
4hr group) received the index procedures with a 10 mL intra-articular injection of TXA and
following drainage clamped 4 hours. Group 2 patients(TXA 8hr group) received the index
procedures with a 10 mL intra-articular injection of TXA and following drainage clamped 8
hours. Clinical evaluations using an IKDC functional score and a Visual Analogue Scale (VAS)
pain score were performed during admission, at postoperative day 3 and week 4.
Description:
Surgical technique All patients participating in this study received surgery by the same
surgeon (H.L.M.) with spinal anesthesia. Pneumatic tourniquet was routinely utilized during
the procedure. A 3-cm incision was made over the medial proximal tibia to harvest the
semitendinosus and gracilis tendons from the distal insertion. The tendons were quadrupled
and whipstitched with No. 2 and No. 5 Ethibond sutures (Ethicon, Somerville, NJ) as
previously described.12 The folded tendons' diameters were measured using sizing cylinders
with 0.5 mm incremental changes in size. The femoral sockets were created by drilling from
the insertion site at the lateral femoral condyle through the anteromedial portal. The tibial
tunnel was drilled with an Acufex guide (Smith & Nephew, Andover, MA). The diameters of the
sockets were matched to the size of the folded graft. The grafts were fixed with bioscrews
(BioRCI-HA; Smith & Nephew) at the femoral site and at the tibial site with the knee flexed
at 30°. The screw and tunnel sizes were identical. Following the procedure, a Hemovac suction
drain (Zimmer, Warsaw, IN) was placed at the superior-lateral aspect of the joint.
Additionally, in the TXA group, 10 mL of TXA solution (100 mg/mL; Daiichi Sankyo, Tokyo,
Japan) was injected into the joint, and all closed suction drains were clamped for 4, or 8
hours based on the grouping results.
Clinical evaluation Postoperative drainage output is the primary outcome of this study. The
drain tubes were routinely removed postoperatively once the volume of drainage decreased, of
which the total volume was recorded. The secondary outcomes included visual analog scale
(VAS) and International Knee Documentation Committee (IKDC) functional score. The former was
documented immediately after patients were transferred back to the ward from the
post-anesthesia recovery room, on day 3 and at week 4 after surgery. Besides, the maximum of
postoperative VAS score during admission was also documented. IKDC functional score was a
subjective questionnaire including three categories with symptoms, athletic activity, and
knee function. Higher score indicated better function with highest score of 10 and lowest of
0. All the objective measurements followed at postoperative 4 week were evaluated by an
independent observer who was blinded to this study at the outpatient clinic.
Statical analysis The power calculation was calculated using the G*Power software (version
3.1; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). The volume of drainage
between groups from our previous study was used as the primary variable. With a power of 0.8
and a significance level of .05, a total of 49 patients were required for each group.
Oversampling of patients in each group was performed due to potential withdrawals and losses
to follow-up. All data are expressed as mean and 95% confidence interval or standard
deviation. The amounts of drainage and the functional scores were compared among four groups
with Analysis of Variance(ANOVA) with post-hoc Tukey Honestly Significant Difference test.
All statistical analyses were conducted using SPSS software (version 22.0, IBM, Armonk, NY).
Differences were considered significant at P < 0.05.
