Osteoarthritis of the knee Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
1. Arthroscopic lavage (+/- debridement as deemed clinically necessary)
2. Placebo arthroscopic lavage
3. Non-operative management with specialist re-assessment
Sponsors
Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (18 years or older) with radiological evidence of osteoarthritis (OA) of the knee who might routinely be considered for arthroscopic lavage 2. Fit for general anaesthetic (American Society of Anesthesiologists [ASA] grade 1 and 2) 3. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patients for whom the orthopaedic surgeon judges that arthroscopic lavage is clearly indicated 2. Patients for whom arthroplasty is clearly indicated 3. Clear contraindication to general anaesthesia 4. Inability to fill in follow-up questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To examine whether the trial processes as currently planned are appropriate, feasible and acceptable to patients, clinicians and the trial office staff 2. To quantify the throughput of eligible patients 3. To quantify the number of patients approached and the proportion of patients who would accept randomisation to the trial 4. To examine the acceptability of the trial information material to patients | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary research outcomes of the main trial (in which we anticipate the pilot patients' data being included) are: 1. General quality of life as measured by 12-item short form questionnaire (SF-12) 2. Patient utility as measured by EQ5D 3. Non-steroidal anti-inflammatory drug (NSAID) or analgesic use 4. Use of other treatments outside the trial interventions 5. Use and cost of health services 6. Cost-effectiveness - incremental cost per quality adjusted life year gained | — |
Countries
United Kingdom
Outcome results
None listed