Septic ArthritisNCT04786379
Surgical Management of Knee Septic Arthritis
A study testing Arthroscopic Irrigation and Debridement and Open Arthrotomy with irrigation and debridement in people with Septic Arthritis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- Arthroscopic Irrigation and Debridement and Open Arthrotomy with irrigation and debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (>18 years old)
- Have a diagnosis of septic arthritis of the native knee (synovial WBC >50k or acrystalline elevated synovial WBC >25,000 with high clinical suspicion)
- Willingness to participate in the study
Who cannot join
- Unwilling to participate in the study
- Acrystalline elevated synovial WBC < 25,000
- Crystalline arthropathy with elevated synovial WBC but < 50,000
- Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center of El Paso
El Paso, Texas, 79905
About this study
Official title: Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial
Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores.
- Conditions
- Septic Arthritis
- Being tested
- Arthroscopic Irrigation and Debridement, Open Arthrotomy with irrigation and debridement
- Keywords
- orthopedic, septic arthritis, synovectomy
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Irrigation and DebridementProcedure or surgery
Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.
Open Arthrotomy with irrigation and debridementProcedure or surgery
Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed septic arthritis of the native knee | Experimental | Not described Receives: Procedure: Arthroscopic Irrigation and Debridement; Procedure: Open Arthrotomy with irrigation and debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgeries to obtain lasting clinical resolution
The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
Measured: Through time period of initial admission (days; expected under 14 days)
Hospital length of stay
The total number of days in which the patient is initially admitted in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
Measured: Through time period of initial admission (days; expected under 14 days)
Secondary outcomes (3)
Post Operative Pain Scores
Daily morning and afternoon visual analogue scale reported by nursing staff. This value is reported on a scale of 0-10; a score of 0 indicates no pain while 10 indicates unbearable pain
Measured: Through time period of initial admission (days; expected under 14 days)
Post Operative Opioid Use
All patients will have post operative pain medications which are to be utilized in a step wise manner for treating their pain. For example, if they are in minimal pain they will be given tylenol whereas unbearable pain will be treated with opioid analgesics. The average total post-operative opioid usage during initial admission will be reported as total morphine milligram equivalent.
Measured: Through time period of initial admission (days; expected under 14 days)
Lysholm Knee Scale
The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting. The scoring is between 0-100 points. A score of <65 indicates poor knee function, 65-83 indicates fair knee function, 84-94 indicates a fair outcome, and 95-100 indicates excellent knee function. This scoring system will be obtained at 2 week, 6 week, and 3 months.
Measured: Through anticipated follow up period of 3 month post operative appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Why it stopped: Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Wells, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Adam Adler, MD, Study director, Texas Tech University Health Sciences Center of El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786379
- Sponsor's protocol ID
- IRB #E21085
- Status last verified
- Dec 2023
- First submitted
- 24 Feb 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hunter JG, Gross JM, Dahl JD, Amsdell SL, Gorczyca JT. Risk factors for failure of a single surgical debridement in adults with acute septic arthritis. J Bone Joint Surg Am. 2015 Apr 1;97(7):558-64. doi: 10.2106/JBJS.N.00593.
PubMed 25834080Bohler C, Dragana M, Puchner S, Windhager R, Holinka J. Treatment of septic arthritis of the knee: a comparison between arthroscopy and arthrotomy. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3147-3154. doi: 10.1007/s00167-015-3659-8. Epub 2015 May 28.
PubMed 26017744Wirtz DC, Marth M, Miltner O, Schneider U, Zilkens KW. Septic arthritis of the knee in adults: treatment by arthroscopy or arthrotomy. Int Orthop. 2001;25(4):239-41. doi: 10.1007/s002640100226.
PubMed 11561499Aim F, Delambre J, Bauer T, Hardy P. Efficacy of arthroscopic treatment for resolving infection in septic arthritis of native joints. Orthop Traumatol Surg Res. 2015 Feb;101(1):61-4. doi: 10.1016/j.otsr.2014.11.010. Epub 2015 Jan 23.
PubMed 25623272
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial
- ClinicalTrials.gov ID
- NCT04786379
- Acronym / sponsor ID
- IRB #E21085
- Conditions
- Septic Arthritis
- Keywords
- orthopedic, septic arthritis, synovectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Mar 2021 (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.
Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed septic arthritis of the native knee | Experimental | Procedure: Arthroscopic Irrigation and Debridement, Procedure: Open Arthrotomy with irrigation and debridement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18 years old)
- Have a diagnosis of septic arthritis of the native knee (synovial WBC >50k or acrystalline elevated synovial WBC >25,000 with high clinical suspicion)
- Willingness to participate in the study
Key exclusion criteria (4 listed)
- Unwilling to participate in the study
- Acrystalline elevated synovial WBC < 25,000
- Crystalline arthropathy with elevated synovial WBC but < 50,000
- Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)
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 |
|---|---|---|
| Arthroscopic Irrigation and DebridementPatients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy. | Procedure or surgery | Patients with confirmed septic arthritis of the native knee |
| Open Arthrotomy with irrigation and debridementPatients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy. | Procedure or surgery | Patients with confirmed septic arthritis of the native knee |
Primary outcome
Number of surgeries to obtain lasting clinical resolution
Time frame: Through time period of initial admission (days; expected under 14 days)
The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
Hospital length of stay
Time frame: Through time period of initial admission (days; expected under 14 days)
The total number of days in which the patient is initially admitted in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
3 secondary outcomes
Post Operative Pain Scores
Time frame: Through time period of initial admission (days; expected under 14 days)
Post Operative Opioid Use
Time frame: Through time period of initial admission (days; expected under 14 days)
Lysholm Knee Scale
Time frame: Through anticipated follow up period of 3 month post operative appointment.
Results and safety
The study was stopped early (reason given: Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 25834080Hunter JG, Gross JM, Dahl JD, Amsdell SL, Gorczyca JT. Risk factors for failure of a single surgical debridement in adults with acute septic arthritis. J Bone Joint Surg Am. 2015 Apr 1;97(7):558-64. doi: 10.2106/JBJS.N.00593.
- Background: PubMed 26017744Bohler C, Dragana M, Puchner S, Windhager R, Holinka J. Treatment of septic arthritis of the knee: a comparison between arthroscopy and arthrotomy. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3147-3154. doi: 10.1007/s00167-015-3659-8. Epub 2015 May 28.
- Background: PubMed 11561499Wirtz DC, Marth M, Miltner O, Schneider U, Zilkens KW. Septic arthritis of the knee in adults: treatment by arthroscopy or arthrotomy. Int Orthop. 2001;25(4):239-41. doi: 10.1007/s002640100226.
- Background: PubMed 25623272Aim F, Delambre J, Bauer T, Hardy P. Efficacy of arthroscopic treatment for resolving infection in septic arthritis of native joints. Orthop Traumatol Surg Res. 2015 Feb;101(1):61-4. doi: 10.1016/j.otsr.2014.11.010. Epub 2015 Jan 23.
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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.
Adam Adler, MD study director
Texas Tech University Health Sciences Center of El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Irrigation and Debridement and Open Arthrotomy with irrigation and debridement in people with Septic Arthritis, run by Texas Tech University Health Sciences Center, El Paso 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 4 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: stopped early, as of the sponsor's last update on 8 Dec 2023. 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?
The study was stopped early (reason given: Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of surgeries to obtain lasting clinical resolution (time frame: Through time period of initial admission (days; expected under 14 days)). The study lists 2 primary outcomes in all. 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 NCT04786379, which also lists 4 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 8 Dec 2023.