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. 2022 Mar 3;2022(3):CD014328. doi: 10.1002/14651858.CD014328

Kirkley 2008.

Study characteristics
Methods Study design: single centre, parallel‐group, two‐arm, randomised, controlled trial
Setting: Fowler Kennedy Sport Medicine Clinic, University of Western Ontario, London, Ontario, Canada
Trial time period: participants were enrolled between January 1999 and August 2007
Interventions: arthroscopic surgery plus optimised physical and medical therapy, home exercises and arthritis education versus optimised physical and medical therapy, home exercises and arthritis education
Sample size calculations: assignment of 186 participants to treatment would provide 80% statistical power to detect a 200‐point difference in the WOMAC score between the two treatment groups with allowance of 15% of participants whose data cannot be evaluated
Analysis: intention‐to‐treat analysis was conducted
Participants Number of participants

  • Number screened: 277 (58 ineligible, 31 declined participation)

  • Number of participants at enrolment: 188

  • Number randomised: 188: 94 in the arthroscopy group and 94 in the physical and medical therapy group. 6 participants in the surgery group declined surgery

  • Number included in analyses: 168: 88 in the arthroscopy group and 80 in the physical and medical therapy group (at 24 months)


Criteria for defining knee osteoarthritis: participants with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren–Lawrence classification
Inclusion criteria

  • 18 years of age or older

  • Idiopathic or secondary osteoarthritis of the knee

  • Grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren–Lawrence classification


Exclusion criteria

  • Large meniscal tears (“bucket handle” tears) as detected by clinical examination or by MRI

  • Inflammatory or post‐infectious arthritis

  • Previous arthroscopic treatment for knee osteoarthritis

  • More than 5 degrees of varus or valgus deformity

  • Previous major knee trauma, Kellgren–Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age

  • Intra‐articular glucocorticoid injection within the previous 3 months

  • A major neurologic deficit

  • Serious medical illness (life expectancy of less than 2 years or high intra‐operative risk)

  • Pregnancy

  • Inability to provide informed consent or who were deemed unlikely to comply with follow‐up


Baseline characteristics
Arthroscopic Surgery (N = 92)

  • Mean (SD) age: 58.6 (10.2) years

  • Number of men and women: M/F = 38/52

  • Mean (SD) body‐mass index: 31.6 (6.7)

  • Mean (SD) WOMAC total score 1187 (483); pain dimension 239 (105); stiffness dimension 117 (50); physical‐function score: 830 (355)

  • Mean (SD) standard‐gamble utility score 0.79 (0.23)

  • Mean (SD) duration of osteoarthritis symptoms in study knee (months) 47.1 (69.4)

  • Mean (SD) SF‐36 physical activity score: 33.8 (7.6)

  • Kellgren–Lawrence grade — no. (%): 2‐ 42 (46); 3‐ 45 (49); 4‐5 (5)

  • No. (%) symptoms of catching or locking: 48 (52)

  • No.(%) joint effusion: 56 (61)

  • No. (%) positive McMurray test: 1 (1)

  • No. (%) pain with forced flexion: 62 (67)

  • No. (%) tenderness at the tibiofemoral joint line: 81 (88)

  • No. (%) magnetic resonance imaging performed: 15 (16)


Physical and Medical Therapy (N = 86)

  • Mean (SD) age: 60.6 (9.9) years

  • Number of men and women: M/F = 28/58

  • Mean (SD) body‐mass index: 30.2 (6.3)

  • Mean (SD) WOMAC total score 1043 (542); pain dimension 214 (122); stiffness dimension 103 (48); physical‐function score: 726 (397)

  • Mean (SD) duration of osteoarthritis symptoms in study knee (months) 40.1 (72.6)

  • Mean (SD) SF‐36 physical activity score: 33.9 (8.6)

  • Mean (SD) standard‐gamble utility score 0.81 (0.20)

  • Kellgren–Lawrence grade — no. (%): 2‐ 36 (42) ; 3‐ 46 (53); 4‐ 4 (5)

  • No. (%) symptoms of catching or locking: 38 (44)

  • No.(%) joint effusion: 53 (62)

  • No. (%) positive McMurray test: 1 (1)

  • No. (%) pain with forced flexion: 56 (65)

  • No. (%) tenderness at the tibiofemoral joint line: 77 (90)

  • No. (%) magnetic resonance imaging performed: 10 (12)


Pre‐treatment group differences: participants in the surgery group had slightly higher total WOMAC scores compared to those in the physical and medical therapy group. Other baseline characteristics were similar across the two groups.
Interventions Arthroscopic surgery:
Arthroscopic surgery plus optimised physical and medical therapy, home exercises and arthritis education. Arthroscopic debridement was performed under general anaesthesia. Irrigation of the medial, lateral, and patellofemoral joint compartments was done using 1 litre of saline. One or more of the following procedures was done ‐ synovectomy; debridement; or excision of degenerative tears of the menisci, fragments of articular cartilage, or chondral flaps and osteophytes. Optimised physical and medical therapy was initiated within 7 days after surgery and followed an identical program in both groups.
Exercise:
Physical and medical therapy, home exercises and arthritis education provided to both groups. Physical therapy was provided for 1 hour once a week for 12 consecutive weeks. Information regarding a home exercise program that emphasised range‐of‐motion and strengthening exercises was provided to all participants. These exercises were done twice daily and once on the day of a scheduled physical‐therapy session. After 12 weeks of supervised activity, participants continued an unsupervised exercise program at home for the duration of the study. The participants received additional education from attendance at local Arthritis Society workshops, from a copy of The Arthritis Helpbook that was provided to them, and from an educational videotape.
The medical therapy for both groups involved the administration of intra‐articular injection of hyaluronic acid, oral glucosamine and step‐wise use of acetaminophen and non‐steroidal anti‐inflammatory drugs.
Outcomes Outcomes were measured at baseline and at 3, 6, 12, 18 and 24 months of follow‐up
Primary outcome
The total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range, 0 to 2400; higher scores indicate more severe symptoms and poorer physical function) at 2 years of follow‐up.
Secondary outcomes

  • WOMAC ‐ Pain, Stiffness and Physical Function subscales scores (range from 0 to 2400; higher scores indicate more severe pain and stiffness and poorer knee function)

  • Short Form‐36 (SF‐36) Physical Component Summary score (range 0 to 100; higher scores indicate better quality of life)

  • McMaster‐Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) assessing symptoms and functional status (scores range from 0 to 500; higher scores indicate greater disability)

  • Arthritis Self‐Efficacy Scale (ASES) assessing perceived ability to cope with the consequences of arthritis (scores range from 10 to 100; higher scores indicate greater self‐efficacy)

  • Health‐related quality of life was assessed by the standard‐gamble utility technique; scores can range from 0.0 (death) to 1.0 (perfect health)


Outcomes used in this review at 3, 6 and 24 months

  • Pain measured on WOMAC‐Pain subscale (0 to 2400, lower score = less pain)

  • Function measured using WOMAC Physical Function subscale (0 to 2400, lower score = better function) (we multiplied the mean values by –1 so that higher scores = better function, as per Cochrane Handbook guidance, so direction was consistent across function scales)

  • Generic health‐related quality of life measured using the standard‐gamble utility score (score range 0 = death to 1 = perfect health)
Notes Funding: this study was sponsored by the Fowler Kennedy Sport Medicine Clinic and supported by the Canadian Institutes of Health Research.
Trial registration: Clinical trials number NCT00158431
Adverse events: unclear if measured; not reported
Knee surgery (replacement or osteotomy): not reported
Progression of knee OA: not reported
Withdrawals: 6/94 in the arthroscopy group and 14/94 in the physical and medical therapy group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned using a computer‐generated schedule.
Allocation concealment (selection bias) Low risk To minimise the risk of predicting the treatment assignment of the next eligible participant, randomisation was performed in permuted blocks of two or four with random variation of the blocking number.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of study staff was done ‐ "To preserve blinding, each patient wore a neoprene sleeve over the knee so that the study nurse could not identify a surgical scar". Blinding of participants was not done.
Blinding of outcome assessor
Self‐reported outcomes High risk As blinding of participants was not done, there could be bias in the assessment of pain, stiffness, disability, quality of life and functional status.
Blinding of outcome assessor
Assessor‐reported outcome (knee replacement) Low risk "At each visit, the patients were evaluated by a nurse who was unaware of the treatment assignment."
Incomplete outcome data (attrition bias)
All outcomes High risk 6/94 (6%) (withdrawal of consent ‐ 2; withdrawal from study ‐ 1; death ‐ 1; loss to follow‐up ‐ 2) in the arthroscopy group and 14/94 (15%) (withdrawal of consent ‐ 8; loss to follow‐up ‐ 6) in the physical and medical therapy group did not complete the study
Selective reporting (reporting bias) Low risk All outcomes listed in the trial registration and protocol have data reported in the results publication.
Other bias Low risk No other bias apparent