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Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with confirmed septic arthritis of the native knee | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic Irrigation and Debridement | Procedure | Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through time period of initial admission (days; expected under 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through time period of initial admission (days; expected under 14 days) |
| Post Operative Opioid Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Adler, MD | Texas Tech University Health Sciences Center of El Paso | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of El Paso | El Paso | Texas | 79905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25834080 | Background | 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. | |
| 26017744 | Background | Bohler 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2021 | Feb 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2021 | Feb 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001170 | Arthritis, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003646 | Debridement |
| D007507 | Therapeutic Irrigation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
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Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
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| Open Arthrotomy with irrigation and debridement | Procedure | Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy. |
|
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. |
| 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. | Through anticipated follow up period of 3 month post operative appointment. |
| 11561499 | Background | Wirtz 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. |
| 25623272 | Background | Aim 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. |
| D012046 |
| Rehabilitation |
| D008919 | Investigative Techniques |