Rotator Cuff TearsNCT07686705
Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair
A study testing Tranexamic acid (intra-articular) and Tranexamic acid (intravenous) in people with Rotator Cuff Tears, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Tranexamic acid (intra-articular) and Tranexamic acid (intravenous)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 May 2023to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Diagnosed with a rotator cuff tear
- Failure of conservative treatment for more than 3 months
- Rotator cuff deemed repairable on magnetic resonance imaging
Who cannot join
- Known hypersensitivity to tranexamic acid
- Previous cerebrovascular accident
- Coronary stent or other history of thromboembolic disease
- Anticoagulant therapy
- Uncontrolled hypertension (systolic pressure > 180 mmHg)
- Abnormal prothrombin time or activated partial thromboplastin time
- Acute traumatic rotator cuff tear
- Irreparable rotator cuff tear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial
This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.
- Conditions
- Rotator Cuff Tears
- Being tested
- Tranexamic acid (intra-articular), Tranexamic acid (intravenous)
- Keywords
- rotator cuff repair, tranexamic acid, visual clarity, shoulder arthroscopy, intra-articular administration
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (intra-articular)Drug
500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.
Tranexamic acid (intravenous)Drug
1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation. |
| Intra-articular TXA | Experimental | Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair. Receives: Drug: Tranexamic acid (intra-articular) |
| Intravenous TXA | Experimental | Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group. Receives: Drug: Tranexamic acid (intravenous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative visual clarity
Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.
Measured: Intraoperatively, at the end of each of the six surgical stages
Secondary outcomes (6)
Total operative time
Total duration of the surgical procedure.
Measured: Intraoperative (duration of surgery)
Estimated blood loss
Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al.
Measured: postoperative day 1
Irrigation-fluid volume
Total volume of irrigation fluid used during the procedure.
Measured: Intraoperatively, from skin incision to skin closure (duration of surgery)
Number of irrigation-pressure increases
Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field
Measured: Intraoperatively, from skin incision to skin closure (duration of surgery)
Postoperative shoulder swelling
Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted ~30 degrees, compared between pre-operative and postoperative day 1
Measured: Baseline (pre-operative) and postoperative day 1
Postoperative pain
Pain assessed using a visual analog scale (VAS) on postoperative day 1
Measured: Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start18 May 2023
- Primary completion25 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Won Chung, MD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686705
- Sponsor's protocol ID
- 2022-12-017
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07686705
- Acronym / sponsor ID
- 2022-12-017
- Conditions
- Rotator Cuff Tears
- Keywords
- rotator cuff repair, tranexamic acid, visual clarity, shoulder arthroscopy, intra-articular administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation. |
| Intra-articular TXA | Experimental | Drug: Tranexamic acid (intra-articular)Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair. |
| Intravenous TXA | Experimental | Drug: Tranexamic acid (intravenous)Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Diagnosed with a rotator cuff tear
- Failure of conservative treatment for more than 3 months
- Rotator cuff deemed repairable on magnetic resonance imaging
Key exclusion criteria (8 listed)
- Known hypersensitivity to tranexamic acid
- Previous cerebrovascular accident
- Coronary stent or other history of thromboembolic disease
- Anticoagulant therapy
- Uncontrolled hypertension (systolic pressure > 180 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid (intra-articular)500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid. | Drug | Intra-articular TXA |
| Tranexamic acid (intravenous)1000 mg of tranexamic acid administered intravenously 10 minutes before surgery. | Drug | Intravenous TXA |
Primary outcome
Intraoperative visual clarity
Time frame: Intraoperatively, at the end of each of the six surgical stages
Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.
6 secondary outcomes
Total operative time
Time frame: Intraoperative (duration of surgery)
Estimated blood loss
Time frame: postoperative day 1
Irrigation-fluid volume
Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)
Number of irrigation-pressure increases
Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)
Postoperative shoulder swelling
Time frame: Baseline (pre-operative) and postoperative day 1
Postoperative pain
Time frame: Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
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Rotator Cuff Tears, Muscle Atrophy or Weakness
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Voll Non-Degradable Shoulder Spacer FIH Study
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Active, not recruitingPhase 2
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruiting
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Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok Won Chung, MD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid (intra-articular) and Tranexamic acid (intravenous) in people with Rotator Cuff Tears, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative visual clarity (time frame: Intraoperatively, at the end of each of the six surgical stages). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.