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Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fractures

The Effect of Early Saline Lavage on Synovial Fluid Composition Following Human Intra-Articular Ankle Fracture

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05465382
Enrollment
41
Registered
2022-07-19
Start date
2022-07-22
Completion date
2024-05-07
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-Articular Fractures

Brief summary

The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

Detailed description

Saline joint lavage represents a potentially simple, low-risk and minimal-cost intervention which has not been previously studied for the purpose of reducing the post-fracture inflammatory burden in human subjects. Open joint lavage at the time of definitive surgical fixation is within the standard of care, but typically occurs greater than 10 days after injury by which time cartilage degradation has already begun. Early, saline lavage during initial presentation to the emergency department may theoretically alter the progression of the intra-articular inflammatory response by evacuating the bulk of the developing synovial-fluid fracture hematoma. The vast majority of ankle fractures present to the ER or urgent care within a day of fracture. Moreover, a large subset of these fractures require reduction (fracture setting) that is painful. It is our standard of care to perform an intra-articular lidocaine injection before reduction. We will take advantage of this standard of care needle insertion to the fractured ankle to perform saline joint lavage to diminish this early inflammatory burden. Adult patients presenting to the Duke University Hospital Emergency Department with an intra-articular fracture of the ankle joint between 0-48 hours from the time of injury will be eligible for inclusion. Patients will be randomized into one of two groups: 1) intra-articular saline lavage, vs 2) no intra-articular saline lavage. Intra-articular aspiration of synovial fluid from the injured ankle will occur both at the time of presentation to the emergency department and at the time of surgery. These synovial fluid samples will be analyzed for differences in key pro-inflammatory cytokines, matrix metalloproteinases and cartilage breakdown products to determine if early saline lavage effects the composition of the synovial fluid micro-environment.

Interventions

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.

OTHERNo intra-articular saline lavage

Subjects in group 2 will not undergo normal saline lavage.

DRUGLidocaine - intra-articular injection

Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.

Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Randomization will occur by the opening of pre-prepared envelopes which will be stored in the orthopaedic resident office. Envelopes will be labeled #1-#60. Thirty envelopes will contain a note card labeled "Group 1" and Thirty envelopes will contain a note card labeled "Group 2". Envelopes will be pre-prepared by key study personnel not involved in the consent or randomization process.

Intervention model description

Patients will be randomized into one of two groups: 1) intra-articular saline lavage, vs 2) no intra-articular saline lavage. Intra-articular aspiration of synovial fluid from the injured ankle will occur both at the time of presentation to the emergency department and at the time of surgery.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult subjects (over 18 years of age) * Must be treated at Duke University Hospital Emergency Department * Intra-articular fracture of the ankle joint (any fracture of the fibula or tibia in which the fracture line(s) exit into the cartilage surface of the ankle joint) * Subjects presenting between 0-48 hours from the time of injury

Exclusion criteria

* Age \< 18 y.o. * Open fracture * Nonoperatively treated fractures * Subjects presenting \>48 hours from the time of injury

Design outcomes

Primary

MeasureTime frameDescription
Change in Cytokine Levels at Specific Time Points After InjuryBaseline (within 24 hours of injury), 1 to 2 weeks post-injuryReported as the total change between baseline and 1 to 2 weeks post-injury.
Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After InjuryBaseline (within 24 hours of injury), 1 to 2 weeks post-injuryReported as the total change between baseline and 1 to 2 weeks post-injury.
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After InjuryBaseline (within 24 hours of injury), 1 to 2 weeks post-injuryReported as the total change between baseline and 1 to 2 weeks post-injury.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSamuel Adams, MD

Duke Health

Baseline characteristics

Characteristic
Age, Continuous50 years
Days from injury aspirate to surgical aspirate9.9 days
Number of fracture lines
1
1 Participants
Number of fracture lines
2
6 Participants
Number of fracture lines
3
4 Participants
Number of fracture lines
4+
2 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
18 Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 10
other
Total, other adverse events
0 / 80 / 10
serious
Total, serious adverse events
0 / 80 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026