Arthroplasty, Replacement, Knee
Conditions
Keywords
Arthropathy, Arthropathy Related to Infection, Arthropathy of Knee Joint, One-stage, Two-stage, Infection, Prosthetic joint infection
Brief summary
Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.
Interventions
PROCEDUREOne-stage
A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.
PROCEDURETwo-stage
A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.
Sponsors
University of Exeter
Nuffield Orthopaedic Centre NHS Trust
Nottingham University Hospitals NHS Trust
Wrightington, Wigan and Leigh NHS Foundation Trust
Royal Devon and Exeter NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinding of participants and trial personnel will not be possible due to the nature of the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery * Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery. * Case meets the International Consensus Meeting criteria for infection * Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable
Exclusion criteria
* Unable or unwilling to undergo either treatment * Lacking capacity to consent to research * Refusal to consent to study for any reason * Re-revision of prosthetic knee infection if first revision was for infection * Presence of tuberculosis infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of recruitment of participants | 20 months | Number of recruits compared to the number of potential participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for non-participation | 20 months | Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial. |
| Patient experience | 2 weeks after surgery | Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview. |
| Surgeon experience | 20 months | Experience of the process of recruitment, randomisation and study participation including thoughts about trial design via qualitative analysis of semi-structured interview after each patient surgery and at the end of the trial. |
| Protocol adherence | 20 months | Assessment of any deviations or violations to protocol that occur during the trial. |
| Explaining the study | 20 months | Assessment of the process of explaining the study (explanation/recruitment/randomisation) between patients and surgeons via qualitative analysis of audio recording of pre-operative discussions about entering the study. |
| Comparison of two sites | 20 months | Recruitment and attrition rates at the two sites |
| Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates | 20 months | Patient-reported questionnaire assessing short-term and long-term symptoms and function in patients with knee injury to be administered pre-, 3 months and 6 months post-operatively |
| Oxford Knee Score (OKS) outcome and completion rates | 20 months | Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively |
| EQ-5D-5L outcome and completion rates | 20 months | Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively |
| Healthcare resource utilisation | 20 months | Patient-reported questionnaire assessing heath and social resource use through an adapted questionnaire of the Client Service Receipt Inventory (CSRI) at 3 and 6 months post-operatively |
Countries
United Kingdom
Outcome results
None listed