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| Name | Class |
|---|---|
| Odense Patient Data Explorative Network | OTHER |
| Region of Southern Denmark | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-stage | Experimental | one-stage surgical treatment of the infected knee arthroplasty |
|
| two-stage | Active Comparator | two-stage surgical treatment of the infected knee arthroplasty with a interim period of 8-10 weeks between stages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| one-stage | Procedure | one-stage surgery |
| |
| two-stage |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (AUC) | Area Under Curve for Oxford Knee Score | preoperatively 6 weeks, 3, 6, 9, 12 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (AUC) | Area Under Curve for Oxford Knee Score | preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. |
| EQ-5D-5L | Quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lindberg-Larsen | Martin Lindberg-Larsen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26900908 | Background | 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. | |
| 28691647 | Background | 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. |
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According to local interpretation of GDPR. Blinded data can be provided upon request.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Procedure |
two-stage surgery |
|
| preoperatively, 6 weeks, 3, 6, 9, 12, 18 and 24 months postoperatively. |
| Re-revision rate | re-revisions due to infection and other causes | 2 year postoperatively |
| mortality | postoperative mortality | 90 days postoperatively and 1 and 2 year postoperatively |
| readmission rate | postoperative readmission rate | 90 days postoperatively |
| Range of Motion | Range of motion of the infected/operated knee | 2 years postoperatively |
| Copenhagen |
| Denmark |
| Gentofte Hospital | Copenhagen | Denmark |
| Hvidovre Hospital | Copenhagen | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Horsens Hospital | Horsens | Denmark |
| Næstved Hospital | Næstved | Denmark |
| Odense Universitets Hospital | Odense | Denmark |
| Vejle Hospital | Vejle | Denmark |
| 23895421 | Background | 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. |
| 24923669 | Background | 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. |
| 22081299 | Background | 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. |
| 22692517 | Background | 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. |
| 26611899 | Background | 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. |
| 33579256 | Derived | 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. |