An interventional study of One-stage and Two-stage in Arthroplasty, Replacement, Knee, sponsored by Royal Devon and Exeter NHS Foundation Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: One-stage
Procedure: Two-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.
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.
Ease of recruitment of participants
Number of recruits compared to the number of potential participants.
Time frame: 20 months
Explaining the study
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.
Time frame: 20 months
Reasons for non-participation
Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.
Time frame: 20 months
Patient experience
Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.
Time frame: 2 weeks after surgery
Surgeon experience
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.
Time frame: 20 months
Protocol adherence
Assessment of any deviations or violations to protocol that occur during the trial.
Time frame: 20 months
Healthcare resource utilisation
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
Time frame: 20 months
Comparison of two sites
Recruitment and attrition rates at the two sites
Time frame: 20 months
Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates
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
Time frame: 20 months
Oxford Knee Score (OKS) outcome and completion rates
Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively
Time frame: 20 months
EQ-5D-5L outcome and completion rates
Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively
Time frame: 20 months
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Royal Devon and Exeter NHS Foundation Trust