Post-traumatic; ArthrosisNCT05652881
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
A study testing Joint Lavage in people with Post-traumatic; Arthrosis and Tibial Fractures, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic; Arthrosis, Tibial Fractures, Post-Traumatic Osteoarthritis of Ankle
- What is being tested?
- Joint Lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to Jul 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18 years or older
- Present with an axially unstable tibial pilon fracture requiring temporary external fixation followed by delayed definitive internal fixation
- Able to give informed consent
Who cannot join
- Open fractures
- Delayed presentation greater than 72 hours post-injury
- Associated talar body fracture
- Presentation after initial ex-fix placement
- Unreconstructable or unsalvageable joint
- Preexisting ankle arthritis
Show all 11Show fewer
- Previous ankle surgery
- Contralateral ankle injury
- Age less than 18 years
- Pregnant women
- Individuals who are incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Lizabeth Summerfiled, 210-848-9654, LSummerfield@hjf.org
About this study
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.
Read the detailed description
High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in many series and can be upwards of 50% in more highly comminuted fracture patterns. Intraarticular fractures result in an increase in the synovial concentrations of inflammatory cytokines and matrix metalloproteinases. Animal models have demonstrated the irreversible damage a persistent hemarthrosis may have on cartilage viability suggesting that prolonged exposure to blood in this highly pro-inflammatory milieu may further exacerbate the chondral damage from the initial injury. However, the impact of these local inflammatory processes on the risk of post-traumatic arthritis and patient outcomes remain unclear.
The long-term goal of our research is to develop treatment modalities including surgical and pharmaceutical interventions to reduce the risk post-traumatic arthritis and dysfunction following intraarticular fractures. The objective of this study is to determine the effect of ankle joint lavage on the risk of post-traumatic arthritis and patient outcomes following high-energy pilon fractures. First, we will obtain synovial fluid samples from the ankle joint of patients undergoing temporary external fixation of a pilon fracture for cytokine analysis. Then, we will randomize patients to undergo standard treatment with or without ankle joint lavage at the time of external fixation. Patients will undergo repeat synovial fluid analysis at the time of definitive fixation to determine the effect of lavage on the concentration of pro-inflammatory cytokines. Last, patients will be followed for a period of six months after surgery to determine the impact on functional outcomes.
The information generated in this study will substantially add to our understanding of the pathogenesis of post-traumatic arthritis in high-energy pilon fractures.
- Being tested
- Joint Lavage
- Medical subject headings
- Osteoarthritis, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint LavageProcedure or surgery
An arthrotomy will be made at the time of temporary external fixation and 1L normal saline will be used to irrigate the ankle joint.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care treatment for axially unstable tibial pilon fracture will include temporary external fixation followed by delayed definitive fixation. Arthrocentesis of the injured and uninjured ankles will be performed at the time of initial temporary external fixation and again at the time of definitive fixation. |
| Intervention | Experimental | Additional intra-articular joint lavage with 1L normal saline will be performed at the time of initial temporary external fixation in addition to standard of care treatment. Receives: Procedure: Joint Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
The concentration of multiple pro-inflammatory cytokines will be measured in both the injured and non-injured extremity at the time of initial temporary external fixation and definitive fixation.
Measured: 2 years
Secondary outcomes (3)
Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scores will be collected at 3 and 6 months post-operatively. The AOFAS Ankle-hindfoot score is on a scale of 0-100 with higher scores indicating better function.
Measured: 6 months
Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures
We will evaluate radiographs obtained during the first 6 months to determine the presence and severity of post-traumatic arthritis.
Measured: 6 months
Effect of intraarticular lavage on range of motion following high-energy pilon fractures
Range of motion measurements will be obtained at 3 and 6 months post-operatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start15 Jan 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic; ArthrosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brooke Army Medical Center
- Responsible party
- Principal investigator, Benjamin Wheatley, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652881
- Sponsor's protocol ID
- 21-14283
- Other IDs
- R21AR081008
- Status last verified
- May 2024
- First submitted
- 28 Nov 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen SH, Wu PH, Lee YS. Long-term results of pilon fractures. Arch Orthop Trauma Surg. 2007 Jan;127(1):55-60. doi: 10.1007/s00402-006-0225-3. Epub 2006 Sep 27.
PubMed 17004076Pollak AN, McCarthy ML, Bess RS, Agel J, Swiontkowski MF. Outcomes after treatment of high-energy tibial plafond fractures. J Bone Joint Surg Am. 2003 Oct;85(10):1893-900. doi: 10.2106/00004623-200310000-00005.
PubMed 14563795Sands A, Grujic L, Byck DC, Agel J, Benirschke S, Swiontkowski MF. Clinical and functional outcomes of internal fixation of displaced pilon fractures. Clin Orthop Relat Res. 1998 Feb;(347):131-7.
PubMed 9520883De-Las-Heras-Romero J, Lledo-Alvarez AM, Lizaur-Utrilla A, Lopez-Prats FA. Quality of life and prognostic factors after intra-articular tibial pilon fracture. Injury. 2017 Jun;48(6):1258-1263. doi: 10.1016/j.injury.2017.03.023. Epub 2017 Mar 22.
PubMed 28365069Anderson DD, Marsh JL, Brown TD. The pathomechanical etiology of post-traumatic osteoarthritis following intraarticular fractures. Iowa Orthop J. 2011;31:1-20.
PubMed 22096414Adams 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.
PubMed 26449389Adams 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.
PubMed 28891711Adams SB, Leimer EM, Setton LA, Bell RD, Easley ME, Huebner JL, Stabler TV, Kraus VB, Olson SA, Nettles DL. Inflammatory Microenvironment Persists After Bone Healing in Intra-articular Ankle Fractures. Foot Ankle Int. 2017 May;38(5):479-484. doi: 10.1177/1071100717690427. Epub 2017 Jan 31.
PubMed 28142266Wahl EP, Lampley AJ, Chen A, Adams SB, Nettles DL, Richard MJ. Inflammatory cytokines and matrix metalloproteinases in the synovial fluid after intra-articular elbow fracture. J Shoulder Elbow Surg. 2020 Apr;29(4):736-742. doi: 10.1016/j.jse.2019.09.024. Epub 2019 Nov 26.
PubMed 31784384Pham TM, Frich LH, Lambertsen KL, Overgaard S, Schmal H. Elevation of Inflammatory Cytokines and Proteins after Intra-Articular Ankle Fracture: A Cross-Sectional Study of 47 Ankle Fracture Patients. Mediators Inflamm. 2021 Jan 8;2021:8897440. doi: 10.1155/2021/8897440. eCollection 2021.
PubMed 33505222van Meegeren ME, Roosendaal G, Jansen NW, Lafeber FP, Mastbergen SC. Blood-Induced Joint Damage: The Devastating Effects of Acute Joint Bleeds versus Micro-Bleeds. Cartilage. 2013 Oct;4(4):313-20. doi: 10.1177/1947603513497569.
PubMed 26069675Ni GX, Zhou YZ, Chen W, Xu L, Li Z, Liu SY, Lei L, Zhan LQ. Different responses of articular cartilage to strenuous running and joint immobilization. Connect Tissue Res. 2016;57(2):143-51. doi: 10.3109/03008207.2015.1117457. Epub 2015 Dec 2.
PubMed 26631363Campbell TM, Reilly K, Laneuville O, Uhthoff H, Trudel G. Bone replaces articular cartilage in the rat knee joint after prolonged immobilization. Bone. 2018 Jan;106:42-51. doi: 10.1016/j.bone.2017.09.018. Epub 2017 Sep 30.
PubMed 28974461Nomura M, Sakitani N, Iwasawa H, Kohara Y, Takano S, Wakimoto Y, Kuroki H, Moriyama H. Thinning of articular cartilage after joint unloading or immobilization. An experimental investigation of the pathogenesis in mice. Osteoarthritis Cartilage. 2017 May;25(5):727-736. doi: 10.1016/j.joca.2016.11.013. Epub 2016 Dec 1.
PubMed 27916560Al-Ashhab ME. Primary Ankle Arthrodesis for Severely Comminuted Tibial Pilon Fractures. Orthopedics. 2017 Mar 1;40(2):e378-e381. doi: 10.3928/01477447-20161202-04. Epub 2016 Dec 15.
PubMed 27942740
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
- ClinicalTrials.gov ID
- NCT05652881
- Acronym / sponsor ID
- 21-14283
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brooke Army Medical Center
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 15 Dec 2022 (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.
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.
Detailed description
High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in many series and can be upwards of 50% in more highly comminuted fracture patterns. Intraarticular fractures result in an increase in the synovial concentrations of inflammatory cytokines and matrix metalloproteinases. Animal models have demonstrated the irreversible damage a persistent hemarthrosis may have on cartilage viability suggesting that prolonged exposure to blood in this highly pro-inflammatory milieu may further exacerbate the chondral damage from the initial injury. However, the impact of these local inflammatory processes on the risk of post-traumatic arthritis and patient outcomes remain unclear.
The long-term goal of our research is to develop treatment modalities including surgical and pharmaceutical interventions to reduce the risk post-traumatic arthritis and dysfunction following intraarticular fractures. The objective of this study is to determine the effect of ankle joint lavage on the risk of post-traumatic arthritis and patient outcomes following high-energy pilon fractures. First, we will obtain synovial fluid samples from the ankle joint of patients undergoing temporary external fixation of a pilon fracture for cytokine analysis. Then, we will randomize patients to undergo standard treatment with or without ankle joint lavage at the time of external fixation. Patients will undergo repeat synovial fluid analysis at the time of definitive fixation to determine the effect of lavage on the concentration of pro-inflammatory cytokines. Last, patients will be followed for a period of six months after surgery to determine the impact on functional outcomes.
The information generated in this study will substantially add to our understanding of the pathogenesis of post-traumatic arthritis in high-energy pilon fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard of care treatment for axially unstable tibial pilon fracture will include temporary external fixation followed by delayed definitive fixation. Arthrocentesis of the injured and uninjured ankles will be performed at the time of initial temporary external fixation and again at the time of definitive fixation. |
| Intervention | Experimental | Procedure: Joint LavageAdditional intra-articular joint lavage with 1L normal saline will be performed at the time of initial temporary external fixation in addition to standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female age 18 years or older
- Present with an axially unstable tibial pilon fracture requiring temporary external fixation followed by delayed definitive internal fixation
- Able to give informed consent
Key exclusion criteria (11 listed)
- Open fractures
- Delayed presentation greater than 72 hours post-injury
- Associated talar body fracture
- Presentation after initial ex-fix placement
- Unreconstructable or unsalvageable joint
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 |
|---|---|---|
| Joint LavageAn arthrotomy will be made at the time of temporary external fixation and 1L normal saline will be used to irrigate the ankle joint. | Procedure or surgery | Intervention |
Primary outcome
The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
Time frame: 2 years
The concentration of multiple pro-inflammatory cytokines will be measured in both the injured and non-injured extremity at the time of initial temporary external fixation and definitive fixation.
3 secondary outcomes
Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures
Time frame: 6 months
Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures
Time frame: 6 months
Effect of intraarticular lavage on range of motion following high-energy pilon fractures
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 17004076Chen SH, Wu PH, Lee YS. Long-term results of pilon fractures. Arch Orthop Trauma Surg. 2007 Jan;127(1):55-60. doi: 10.1007/s00402-006-0225-3. Epub 2006 Sep 27.
- Background: PubMed 14563795Pollak AN, McCarthy ML, Bess RS, Agel J, Swiontkowski MF. Outcomes after treatment of high-energy tibial plafond fractures. J Bone Joint Surg Am. 2003 Oct;85(10):1893-900. doi: 10.2106/00004623-200310000-00005.
- Background: PubMed 9520883Sands A, Grujic L, Byck DC, Agel J, Benirschke S, Swiontkowski MF. Clinical and functional outcomes of internal fixation of displaced pilon fractures. Clin Orthop Relat Res. 1998 Feb;(347):131-7.
- Background: PubMed 28365069De-Las-Heras-Romero J, Lledo-Alvarez AM, Lizaur-Utrilla A, Lopez-Prats FA. Quality of life and prognostic factors after intra-articular tibial pilon fracture. Injury. 2017 Jun;48(6):1258-1263. doi: 10.1016/j.injury.2017.03.023. Epub 2017 Mar 22.
- Background: PubMed 22096414Anderson DD, Marsh JL, Brown TD. The pathomechanical etiology of post-traumatic osteoarthritis following intraarticular fractures. Iowa Orthop J. 2011;31:1-20.
- Background: PubMed 26449389Adams 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.
- Background: PubMed 28891711Adams 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.
- Background: PubMed 28142266Adams SB, Leimer EM, Setton LA, Bell RD, Easley ME, Huebner JL, Stabler TV, Kraus VB, Olson SA, Nettles DL. Inflammatory Microenvironment Persists After Bone Healing in Intra-articular Ankle Fractures. Foot Ankle Int. 2017 May;38(5):479-484. doi: 10.1177/1071100717690427. Epub 2017 Jan 31.
- Background: PubMed 31784384Wahl EP, Lampley AJ, Chen A, Adams SB, Nettles DL, Richard MJ. Inflammatory cytokines and matrix metalloproteinases in the synovial fluid after intra-articular elbow fracture. J Shoulder Elbow Surg. 2020 Apr;29(4):736-742. doi: 10.1016/j.jse.2019.09.024. Epub 2019 Nov 26.
- Background: PubMed 33505222Pham TM, Frich LH, Lambertsen KL, Overgaard S, Schmal H. Elevation of Inflammatory Cytokines and Proteins after Intra-Articular Ankle Fracture: A Cross-Sectional Study of 47 Ankle Fracture Patients. Mediators Inflamm. 2021 Jan 8;2021:8897440. doi: 10.1155/2021/8897440. eCollection 2021.
- Background: PubMed 26069675van Meegeren ME, Roosendaal G, Jansen NW, Lafeber FP, Mastbergen SC. Blood-Induced Joint Damage: The Devastating Effects of Acute Joint Bleeds versus Micro-Bleeds. Cartilage. 2013 Oct;4(4):313-20. doi: 10.1177/1947603513497569.
- Background: PubMed 26631363Ni GX, Zhou YZ, Chen W, Xu L, Li Z, Liu SY, Lei L, Zhan LQ. Different responses of articular cartilage to strenuous running and joint immobilization. Connect Tissue Res. 2016;57(2):143-51. doi: 10.3109/03008207.2015.1117457. Epub 2015 Dec 2.
- Individual participant dataSharing planned: No
Related trials for Post-traumatic; Arthrosis
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Lavage in people with Post-traumatic; Arthrosis and Tibial Fractures, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin M Wheatley, MD (619-532-5101, benjamin.m.wheatley.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652881, which also lists 25 linked publications.
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 6 May 2024.