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

NCT05465382 | Terminated Results DMC FDA Device

• 1 other identifier: Pro00110537
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra-Articular Fractures

Outcome Measures

Primary Outcomes (3)

• Change in Cytokine Levels at Specific Time Points After Injury

  Reported as the total change between baseline and 1 to 2 weeks post-injury.

  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

  Reported as the total change between baseline and 1 to 2 weeks post-injury.

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

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

  Reported as the total change between baseline and 1 to 2 weeks post-injury.

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

Study Arms (2)

Intra-articular saline lavage

EXPERIMENTAL

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 Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle.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.

Device: Saline Lavage; Drug: Lidocaine - intra-articular injection; Other: Synovial Fluid Aspiration

No intra-articular saline lavage

ACTIVE COMPARATOR

Subjects in group 2 will not undergo normal saline lavage.

Other: No intra-articular saline lavage; Drug: Lidocaine - intra-articular injection; Other: Synovial Fluid Aspiration

Interventions

Synovial Fluid Aspiration OTHER

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

Intra-articular saline lavage; No intra-articular saline lavage

Lidocaine - intra-articular injection DRUG

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

Intra-articular saline lavage; No intra-articular saline lavage

Saline Lavage DEVICE

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.

Intra-articular saline lavage

No intra-articular saline lavage OTHER

Subjects in group 2 will not undergo normal saline lavage.

No intra-articular saline lavage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (13)

• Huch K, Kuettner KE, Dieppe P. Osteoarthritis in ankle and knee joints. Semin Arthritis Rheum. 1997 Feb;26(4):667-74. doi: 10.1016/s0049-0172(97)80002-9.

  PMID: 9062947 BACKGROUND

• Brown TD, Johnston RC, Saltzman CL, Marsh JL, Buckwalter JA. Posttraumatic osteoarthritis: a first estimate of incidence, prevalence, and burden of disease. J Orthop Trauma. 2006 Nov-Dec;20(10):739-44. doi: 10.1097/01.bot.0000246468.80635.ef.

  PMID: 17106388 BACKGROUND

• Delco ML, Kennedy JG, Bonassar LJ, Fortier LA. Post-traumatic osteoarthritis of the ankle: A distinct clinical entity requiring new research approaches. J Orthop Res. 2017 Mar;35(3):440-453. doi: 10.1002/jor.23462. Epub 2016 Nov 8.

  PMID: 27764893 BACKGROUND

• Buckwalter JA, Brown TD. Joint injury, repair, and remodeling: roles in post-traumatic osteoarthritis. Clin Orthop Relat Res. 2004 Jun;(423):7-16.

  PMID: 15232420 BACKGROUND

• McKinley TO, Tochigi Y, Rudert MJ, Brown TD. The effect of incongruity and instability on contact stress directional gradients in human cadaveric ankles. Osteoarthritis Cartilage. 2008 Nov;16(11):1363-9. doi: 10.1016/j.joca.2008.04.005. Epub 2008 Jun 3.

  PMID: 18511308 BACKGROUND

• Dirschl DR, Marsh JL, Buckwalter JA, Gelberman R, Olson SA, Brown TD, Llinias A. Articular fractures. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):416-23. doi: 10.5435/00124635-200411000-00006.

  PMID: 15615507 BACKGROUND

• Giannoudis PV, Tzioupis C, Papathanassopoulos A, Obakponovwe O, Roberts C. Articular step-off and risk of post-traumatic osteoarthritis. Evidence today. Injury. 2010 Oct;41(10):986-95. doi: 10.1016/j.injury.2010.08.003.

  PMID: 20728882 BACKGROUND

• Allen NB, Abar B, Danilkowicz RM, Kraus VB, Olson SA, Adams SB. Intra-Articular Synovial Fluid With Hematoma After Ankle Fracture Promotes Cartilage Damage In Vitro Partially Attenuated by Anti-Inflammatory Agents. Foot Ankle Int. 2022 Mar;43(3):426-438. doi: 10.1177/10711007211046952. Epub 2021 Oct 7.

  PMID: 34617803 BACKGROUND

• Hembree WC, Ward BD, Furman BD, Zura RD, Nichols LA, Guilak F, Olson SA. Viability and apoptosis of human chondrocytes in osteochondral fragments following joint trauma. J Bone Joint Surg Br. 2007 Oct;89(10):1388-95. doi: 10.1302/0301-620X.89B10.18907.

  PMID: 17957084 BACKGROUND

• Adams SB, Setton LA, Bell RD, Easley ME, Huebner JL, Stabler T, Kraus VB, Leimer EM, Olson SA, Nettles DL. Inflammatory Cytokines and Matrix Metalloproteinases in the Synovial Fluid After Intra-articular Ankle Fracture. Foot Ankle Int. 2015 Nov;36(11):1264-71. doi: 10.1177/1071100715611176. Epub 2015 Oct 8.

  PMID: 26449389 BACKGROUND

• Adams SB, Reilly RM, Huebner JL, Kraus VB, Nettles DL. Time-Dependent Effects on Synovial Fluid Composition During the Acute Phase of Human Intra-articular Ankle Fracture. Foot Ankle Int. 2017 Oct;38(10):1055-1063. doi: 10.1177/1071100717728234. Epub 2017 Sep 11.

  PMID: 28891711 BACKGROUND

• Kimmerling KA, Furman BD, Mangiapani DS, Moverman MA, Sinclair SM, Huebner JL, Chilkoti A, Kraus VB, Setton LA, Guilak F, Olson SA. Sustained intra-articular delivery of IL-1RA from a thermally-responsive elastin-like polypeptide as a therapy for post-traumatic arthritis. Eur Cell Mater. 2015 Jan 31;29:124-39; discussion 139-40. doi: 10.22203/ecm.v029a10.

  PMID: 25636786 BACKGROUND

• Furman BD, Mangiapani DS, Zeitler E, Bailey KN, Horne PH, Huebner JL, Kraus VB, Guilak F, Olson SA. Targeting pro-inflammatory cytokines following joint injury: acute intra-articular inhibition of interleukin-1 following knee injury prevents post-traumatic arthritis. Arthritis Res Ther. 2014 Jun 25;16(3):R134. doi: 10.1186/ar4591.

  PMID: 24964765 BACKGROUND

MeSH Terms

Conditions

Intra-Articular Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Samuel G. Lorentz, MD
• Organization: Duke University

samuel.lorentz@duke.edu

(919) 684-8111

Study Officials

• Samuel Adams, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: July 22, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)