## Protocol Section
### Identification Module
**NCT ID:** NCT03435679

**Brief Title:** One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty

**Official Title:** One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. A Randomized Controlled Multicenter Trial.

#### Organization Study ID Info
**ID:** MLL_02_2018
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2027-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2018-02-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-31
**Study First Submit QC Date:** 2018-02-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Odense Patient Data Explorative Network

**Class:** OTHER

**Name:** Region of Southern Denmark

#### Lead Sponsor

**Class:** OTHER

**Name:** Odense University Hospital

#### Responsible Party

**Investigator Affiliation:** Odense University Hospital

**Investigator Full Name:** Martin Lindberg-Larsen

**Investigator Title:** Orthopaedic Surgeon, MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty.

Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure.

The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.

**Detailed Description:** A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies.

The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far.

### Conditions Module

**Conditions:**

- Periprosthetic Knee Infection

**Keywords:**

- infection

- knee arthroplasty

- surgical treatment

- one-stage

- two-stage

- outcome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** one-stage surgical treatment of the infected knee arthroplasty

**Intervention Names:**

- Procedure: one-stage

**Label:** one-stage

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages

**Intervention Names:**

- Procedure: two-stage

**Label:** two-stage

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- one-stage

**Description:** one-stage surgery

**Name:** one-stage

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- two-stage

**Description:** two-stage surgery

**Name:** two-stage

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Area Under Curve for Oxford Knee Score

**Measure:** Oxford Knee Score (AUC)

**Time Frame:** preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively.

#### Secondary Outcomes

**Description:** Area Under Curve for Oxford Knee Score

**Measure:** Oxford Knee Score (AUC)

**Time Frame:** preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

**Description:** Quality of life questionnaire

**Measure:** EQ-5D-5L

**Time Frame:** preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively.

**Description:** re-revisions due to infection and other causes

**Measure:** Re-revision rate

**Time Frame:** 2 year postoperatively

**Description:** postoperative mortality

**Measure:** mortality

**Time Frame:** 90 days postoperatively and 1 and 2 year postoperatively

**Description:** postoperative readmission rate

**Measure:** readmission rate

**Time Frame:** 90 days postoperatively

**Description:** Range of motion of the infected/operated knee

**Measure:** Range of Motion

**Time Frame:** 2 years postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Clinical signs of periprosthetic knee infection
* \> 6 weeks from previous knee arthoplasty procedure (primary or total revision procedure)
* Speak and understand Danish and have given informed consent

Exclusion Criteria:

* Soft tissue problems requiring plastic surgery
* major bone loss requiring mega/tumor-prosthesis
* acute surgery due to sepsis
* malignant disease with less than 2 years life expectancy
* re-infection with previous two-stage procedure
* bilateral knee infection

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** martin.lindberg-larsen@rsyd.dk

**Name:** Martin Lindberg-Larsen, MD, PhD

**Phone:** 0045 25213900

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aalborg

**Contacts:**

***Contact 1:***

- **Name:** Andreas Kappel, MD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Aalborg University Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Arhus

**Country:** Denmark

**Facility:** Aarhus University Hospital

**Status:** WITHDRAWN

**Location 3:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Morten Smiegalow, MD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Bispebjerg Hospital

**Status:** RECRUITING

**Location 4:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Anders Odgaard, MD, PhD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Gentofte Hospital

**Status:** RECRUITING

**Location 5:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Kirill Gromov, MD, PhD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Hvidovre Hospital

**Status:** RECRUITING

**Location 6:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Name:** Anders Odgaard, Professor

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Rigshospitalet

**Status:** RECRUITING

**Location 7:**

**City:** Horsens

**Contacts:**

***Contact 1:***

- **Name:** Jeppe Lange, MD, PhD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Horsens Hospital

**Status:** RECRUITING

**Location 8:**

**City:** Køge

**Country:** Denmark

**Facility:** Køge Hospital

**Status:** WITHDRAWN

**Location 9:**

**City:** Næstved

**Contacts:**

***Contact 1:***

- **Name:** Henrik Schrøder, MD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Næstved Hospital

**Status:** RECRUITING

**Location 10:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Name:** Martin Lindberg-Larsen, MD, PhD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Odense Universitets Hospital

**Status:** RECRUITING

**Location 11:**

**City:** Silkeborg

**Country:** Denmark

**Facility:** Silkeborg Hospital

**Status:** WITHDRAWN

**Location 12:**

**City:** Vejle

**Contacts:**

***Contact 1:***

- **Name:** Thomas Bruno Lind-Hansen, MD, PhD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Vejle Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Martin Lindberg-Larsen

**Name:** Martin Lindberg-Larsen

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** According to local interpretation of GDPR. Blinded data can be provided upon request.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Lindberg-Larsen M, Jorgensen CC, Bagger J, Schroder HM, Kehlet H. Revision of infected knee arthroplasties in Denmark. Acta Orthop. 2016 Aug;87(4):333-8. doi: 10.3109/17453674.2016.1148453. Epub 2016 Feb 22.

**PMID:** 26900908

**Citation:** Lindberg-Larsen M, Pitter FT, Voldstedlund M, Schroder HM, Bagger J. Microbiological diagnosis in revision of infected knee arthroplasties in Denmark. Infect Dis (Lond). 2017 Nov-Dec;49(11-12):824-830. doi: 10.1080/23744235.2017.1350878. Epub 2017 Jul 8.

**PMID:** 28691647

**Citation:** Masters JP, Smith NA, Foguet P, Reed M, Parsons H, Sprowson AP. A systematic review of the evidence for single stage and two stage revision of infected knee replacement. BMC Musculoskelet Disord. 2013 Jul 29;14:222. doi: 10.1186/1471-2474-14-222.

**PMID:** 23895421

**Citation:** Haddad FS, Sukeik M, Alazzawi S. Is single-stage revision according to a strict protocol effective in treatment of chronic knee arthroplasty infections? Clin Orthop Relat Res. 2015 Jan;473(1):8-14. doi: 10.1007/s11999-014-3721-8.

**PMID:** 24923669

**Citation:** Singer J, Merz A, Frommelt L, Fink B. High rate of infection control with one-stage revision of septic knee prostheses excluding MRSA and MRSE. Clin Orthop Relat Res. 2012 May;470(5):1461-71. doi: 10.1007/s11999-011-2174-6. Epub 2011 Nov 12.

**PMID:** 22081299

**Citation:** Baker P, Petheram TG, Kurtz S, Konttinen YT, Gregg P, Deehan D. Patient reported outcome measures after revision of the infected TKR: comparison of single versus two-stage revision. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2713-20. doi: 10.1007/s00167-012-2090-7. Epub 2012 Jun 13.

**PMID:** 22692517

**Citation:** Massin P, Delory T, Lhotellier L, Pasquier G, Roche O, Cazenave A, Estellat C, Jenny JY. Infection recurrence factors in one- and two-stage total knee prosthesis exchanges. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3131-3139. doi: 10.1007/s00167-015-3884-1. Epub 2015 Nov 26.

**PMID:** 26611899

**Citation:** Lindberg-Larsen M, Odgaard A, Fredborg C, Schroder HM; One-stage vs Two-stage Collaboration Group. One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol. BMC Musculoskelet Disord. 2021 Feb 12;22(1):175. doi: 10.1186/s12891-021-04044-8.

**PMID:** 33579256

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

### Misc Info Module

- Version Holder: 2024-05-24
