Trial Outcomes & Findings for Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fractures (NCT NCT05465382)
NCT ID: NCT05465382
Last Updated: 2026-04-14
Results Overview
Reported as the total change between baseline and 1 to 2 weeks post-injury.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline (within 24 hours of injury), 1 to 2 weeks post-injury
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
Intra-articular Saline Lavage
Subjects in Group 1 will then undergo saline joint lavage as follows:
Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Saline Lavage: Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
No Intra-articular Saline Lavage
Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage: Subjects in group 2 will not undergo normal saline lavage.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intra-articular Saline Lavage
n=17 Participants
Subjects in Group 1 will then undergo saline joint lavage as follows:
Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Saline Lavage: Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
No Intra-articular Saline Lavage
n=15 Participants
Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage: Subjects in group 2 will not undergo normal saline lavage.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
n=17 Participants
|
52.8 years
n=15 Participants
|
50 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=17 Participants
|
10 Participants
n=15 Participants
|
15 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=17 Participants
|
5 Participants
n=15 Participants
|
17 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 Participants
n=17 Participants
|
10 Participants
n=15 Participants
|
18 Participants
n=32 Participants
|
|
Number of fracture lines
1
|
2 Participants
n=17 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=32 Participants
|
|
Number of fracture lines
2
|
6 Participants
n=17 Participants
|
8 Participants
n=15 Participants
|
14 Participants
n=32 Participants
|
|
Number of fracture lines
3
|
7 Participants
n=17 Participants
|
4 Participants
n=15 Participants
|
11 Participants
n=32 Participants
|
|
Number of fracture lines
4+
|
2 Participants
n=17 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=32 Participants
|
|
Days from injury aspirate to surgical aspirate
|
10.6 days
n=17 Participants
|
9.9 days
n=15 Participants
|
10.3 days
n=32 Participants
|
PRIMARY outcome
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injuryPopulation: Data for IL-4, IL-8, and IL-10 was only collected on the first 18 participants due to observed effect sizes, concentration distributions, biological relevance to post-traumatic inflammation, and predefined resource constraints.
Reported as the total change between baseline and 1 to 2 weeks post-injury.
Outcome measures
| Measure |
Intra-articular Saline Lavage
n=17 Participants
Subjects in Group 1 will then undergo saline joint lavage as follows:
Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Saline Lavage: Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
No Intra-articular Saline Lavage
n=15 Participants
Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage: Subjects in group 2 will not undergo normal saline lavage.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
|---|---|---|
|
Change in Cytokine Levels at Specific Time Points After Injury
IL-1β (Interleukin-1 beta)
|
-11.05 pg/mL
Standard Deviation 7.07
|
-5.30 pg/mL
Standard Deviation 8.31
|
|
Change in Cytokine Levels at Specific Time Points After Injury
IL-6 (Interleukin-6)
|
-810.09 pg/mL
Standard Deviation 1466.54
|
-358.76 pg/mL
Standard Deviation 1625.37
|
|
Change in Cytokine Levels at Specific Time Points After Injury
IL-4 (Interleukin-4)
|
-0.06 pg/mL
Standard Deviation 0.15
|
-0.19 pg/mL
Standard Deviation 0.43
|
|
Change in Cytokine Levels at Specific Time Points After Injury
IL-8 (Interleukin-8)
|
164.06 pg/mL
Standard Deviation 734.56
|
224.05 pg/mL
Standard Deviation 967.49
|
|
Change in Cytokine Levels at Specific Time Points After Injury
IL-10 (Interleukin-10)
|
1.78 pg/mL
Standard Deviation 7.64
|
-0.58 pg/mL
Standard Deviation 2.45
|
PRIMARY outcome
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injuryReported as the total change between baseline and 1 to 2 weeks post-injury.
Outcome measures
| Measure |
Intra-articular Saline Lavage
n=17 Participants
Subjects in Group 1 will then undergo saline joint lavage as follows:
Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Saline Lavage: Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
No Intra-articular Saline Lavage
n=15 Participants
Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage: Subjects in group 2 will not undergo normal saline lavage.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
|---|---|---|
|
Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After Injury
|
0.27 ng/mL
Standard Deviation 0.50
|
0.25 ng/mL
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injuryPopulation: Data for MMP-1, MMP-2, MMP-3, MMP-10, and MMP-13 was only collected on the first 18 participants due to observed effect sizes, concentration distributions, biological relevance to post-traumatic inflammation, and predefined resource constraints.
Reported as the total change between baseline and 1 to 2 weeks post-injury.
Outcome measures
| Measure |
Intra-articular Saline Lavage
n=8 Participants
Subjects in Group 1 will then undergo saline joint lavage as follows:
Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Saline Lavage: Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
No Intra-articular Saline Lavage
n=10 Participants
Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage: Subjects in group 2 will not undergo normal saline lavage.
Lidocaine - intra-articular injection: Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Synovial Fluid Aspiration: Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
|
|---|---|---|
|
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
MMP-1
|
222946.5 pg/mL
Standard Deviation 212067.0
|
359637.5 pg/mL
Standard Deviation 236636.5
|
|
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
MMP-2
|
733202.5 pg/mL
Standard Deviation 390903.2
|
650774.6 pg/mL
Standard Deviation 319990.5
|
|
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
MMP-3
|
1776049.0 pg/mL
Standard Deviation 3625070.9
|
7428056.0 pg/mL
Standard Deviation 11071970.5
|
|
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
MMP-10
|
517.62 pg/mL
Standard Deviation 575.10
|
559.78 pg/mL
Standard Deviation 272.35
|
|
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
MMP-13
|
1746.11 pg/mL
Standard Deviation 3299.68
|
1693.51 pg/mL
Standard Deviation 3321.56
|
Adverse Events
Intra-articular Saline Lavage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intra-articular Saline Lavage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place