## Protocol Section
### Identification Module
**NCT ID:** NCT04786379

**Brief Title:** Surgical Management of Knee Septic Arthritis

**Official Title:** Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial

#### Organization Study ID Info
**ID:** IRB #E21085
#### Organization
**Class:** OTHER
**Full Name:** Texas Tech University Health Sciences Center, El Paso
### Status Module
#### Completion Date
**Date:** 2022-04-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-01

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-04-01

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2021-03-08
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-24
**Study First Submit QC Date:** 2021-03-03
**Why Stopped:** Due to lack of adequate patient sample size in a reasonable time period and lack of research support staff
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Texas Tech University Health Sciences Center, El Paso

#### Responsible Party

**Investigator Affiliation:** Texas Tech University Health Sciences Center, El Paso

**Investigator Full Name:** Matthew Wells

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Septic Arthritis

**Keywords:**

- orthopedic

- septic arthritis

- synovectomy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Arthroscopic Irrigation and Debridement

- Procedure: Open Arthrotomy with irrigation and debridement

**Label:** Patients with confirmed septic arthritis of the native knee

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with confirmed septic arthritis of the native knee

**Description:** Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.

**Name:** Arthroscopic Irrigation and Debridement

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Patients with confirmed septic arthritis of the native knee

**Description:** Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.

**Name:** Open Arthrotomy with irrigation and debridement

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.

**Measure:** Number of surgeries to obtain lasting clinical resolution

**Time Frame:** Through time period of initial admission (days; expected under 14 days)

**Description:** 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.

**Measure:** Hospital length of stay

**Time Frame:** Through time period of initial admission (days; expected under 14 days)

#### Secondary Outcomes

**Description:** 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

**Measure:** Post Operative Pain Scores

**Time Frame:** Through time period of initial admission (days; expected under 14 days)

**Description:** 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.

**Measure:** Post Operative Opioid Use

**Time Frame:** Through time period of initial admission (days; expected under 14 days)

**Description:** 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.

**Measure:** Lysholm Knee Scale

**Time Frame:** Through anticipated follow up period of 3 month post operative appointment.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** El Paso

**Country:** United States

**Facility:** University Medical Center of El Paso

**State:** Texas

**Zip:** 79905

#### Overall Officials

**Official 1:**

**Affiliation:** Texas Tech University Health Sciences Center of El Paso

**Name:** Adam Adler, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 25834080

**Citation:** 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.

**PMID:** 26017744

**Citation:** 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.

**PMID:** 11561499

**Citation:** 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.

**PMID:** 25623272

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-02-19

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 158806

- Type Abbrev: Prot_SAP

- Upload Date: 2021-02-27T05:59

- Date: 2021-02-19

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 161059

- Type Abbrev: ICF

- Upload Date: 2021-02-27T06:00

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4478

- Name: Arthritis, Infectious

- Relevance: HIGH

- As Found: Septic Arthritis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3063

- Name: Infectious Arthritis

- Relevance: HIGH

- As Found: Septic Arthritis

### Condition Browse Module - Meshes

- ID: D000001170

- Term: Arthritis, Infectious

- ID: D000001168

- Term: Arthritis

### Misc Info Module

- Version Holder: 2024-05-24
