TerminatedNot Applicable

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

Stopped: Low accrual

United States41 participantsStarted 2022-07-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Cytokine Levels at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury

Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury

Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury

Trial details

NCT IDNCT05465382

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-07

Results submitted2026-02-11

View on ClinicalTrials.gov More Intra-Articular Fractures trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Cytokine Levels at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury

Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury

Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury

Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury