A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee
J. Bruce Moseley, M.D., Kimberly O'Malley, Ph.D., Nancy J. Petersen, Ph.D., Terri J. Menke, Ph.D., Baruch A. Brody, Ph.D., David H. Kuykendall, Ph.D., John C. Hollingsworth, Dr.P.H., Carol M. Ashton, M.D., M.P.H., and Nelda P. Wray, M.D., M.P.H.
Background Many patients report symptomatic relief after undergoingarthroscopy of the knee for osteoarthritis, but it is unclearhow the procedure achieves this result. We conducted a randomized,placebo-controlled trial to evaluate the efficacy of arthroscopyfor osteoarthritis of the knee.
Methods A total of 180 patients with osteoarthritis of the kneewere randomly assigned to receive arthroscopic débridement,arthroscopic lavage, or placebo surgery. Patients in the placebogroup received skin incisions and underwent a simulated débridementwithout insertion of the arthroscope. Patients and assessorsof outcome were blinded to the treatment-group assignment. Outcomeswere assessed at multiple points over a 24-month period withthe use of five self-reported scores — three on scalesfor pain and two on scales for function — and one objectivetest of walking and stair climbing. A total of 165 patientscompleted the trial.
The college and hospital institutional review board approvedthe protocol. A data and safety monitoring board monitored thestudy.
Study Participants
Participants were recruited from the Houston Veterans AffairsMedical Center from October 1995 through September 1998. Patientswere eligible if they were 75 years old or younger, had osteoarthritisof the knee as defined by the American College of Rheumatology,17reported at least moderate knee pain on average (4 on a visual-analoguescale ranging from 0 to 10) despite maximal medical treatmentfor at least six months, and had not undergone arthroscopy ofthe knee during the previous two years.
The severity of osteoarthritis in the study knee (that withthe greatest pain-induced limitation of function) was assessedradiographically and graded on a scale of zero to four.18 Thescores for the three compartments were added together to generatea severity grade of 0 to 12. Criteria for exclusion were a severitygrade of 9 or higher, severe deformity, and serious medicalproblems.
All patients provided informed consent, which included writingin their chart, "On entering this study, I realize that I mayreceive only placebo surgery. I further realize that this meansthat I will not have surgery on my knee joint. This placebosurgery will not benefit my knee arthritis." Of the 324 consecutivepatients who met the criteria for inclusion, 144 (44 percent)declined to participate. Participants were younger than thosewho declined to participate (52.3±11.3 years vs. 55.3±12.4years, P=0.002), were more likely to be white (62.2 percentvs. 50.7 percent, P=0.03), and had more severe arthritis (25.0percent vs. 12.5 percent with grade 7 or 8 arthritis, P<0.001).
Randomization Process and Treatment Groups
Participants were stratified into three groups according tothe severity of osteoarthritis (grade 1, 2, or 3; grade 4, 5,or 6; and grade 7 or 8). A stratified randomization processwith fixed blocks of six was used. Sealed, sequentially numbered,stratum-specific envelopes containing treatment assignmentswere prepared and given to the research assistant. After thepatient was in the operating suite, the surgeon was handed theenvelope. The treatment assignment was not revealed to the patient.
Participants were randomly assigned to arthroscopic débridement,arthroscopic lavage alone, or the placebo procedure. One orthopedistperformed all the operations. Patients in the débridementgroup or the lavage group received standard general anesthesiawith endotracheal intubation. Patients in the placebo groupreceived a short-acting intravenous tranquilizer and an opioidand spontaneously breathed oxygen-enriched air.
Lavage
After diagnostic arthroscopy in patients in the lavage group,the joint was lavaged with at least 10 liters of fluid. Anythingthat could be flushed out through arthroscopic cannulas wasremoved. Normally, no instruments were used to mechanicallydébride or remove tissue. However, if a mechanicallyimportant, unstable tear in the meniscus (e.g., a displaced"bucket-handle" tear) was encountered, the torn portion wasremoved and the remaining meniscus was smoothed to a firm, stablerim. (There is general agreement that it is inappropriate toleave this type of meniscal tear untreated.11,13,19,20) No otherdébridement was performed.
Débridement
After diagnostic arthroscopy in patients in the débridementgroup, the joint was lavaged with at least 10 liters of fluid,rough articular cartilage was shaved (chondroplasty was performed),loose debris was removed, all torn or degenerated meniscal fragmentswere trimmed, and the remaining meniscus was smoothed to a firmand stable rim. No abrasion arthroplasty or microfracture wasperformed. Typically, bone spurs were not removed, but any spursfrom the tibial spine area that blocked full extension wereshaved smooth.
Placebo Procedure
To preserve blinding in the event that patients in the placebogroup did not have total amnesia, a standard arthroscopic débridementprocedure was simulated. After the knee was prepped and draped,three 1-cm incisions were made in the skin. The surgeon askedfor all instruments and manipulated the knee as if arthroscopywere being performed. Saline was splashed to simulate the soundsof lavage. No instrument entered the portals for arthroscopy.The patient was kept in the operating room for the amount oftime required for a débridement. Patients spent the nightafter the procedure in the hospital and were cared for by nurseswho were unaware of the treatment-group assignment.
Postoperatively, there were two minor complications and no deaths.Incisional erythema developed in one patient, who was givenantibiotics. In a second patient, calf swelling developed inthe leg that had undergone surgery; venography was negativefor thrombosis. In no case did a complication necessitate thebreaking of the randomization code.
Postoperative care was delivered according to a protocol specifyingthat all patients should receive the same walking aids, graduatedexercise program, and analgesics. The use of analgesics aftersurgery was monitored; during the two-year follow-up period,the amount used was similar in the three groups.
End Points
Study personnel who were unaware of the treatment-group assignmentsperformed all postoperative outcome assessments; the operatingsurgeon did not participate in any way. Data on end points werecollected 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18months, and 24 months after the procedure. To assess whetherpatients remained unaware of their treatment-group assignment,they were asked at each follow-up visit to guess which procedurethey had undergone. Patients in the placebo group were no morelikely than patients in the other two groups to guess that theyhad undergone a placebo procedure. For example, at two weeks,13.8 percent of the patients in the placebo group guessed thatthey had undergone a placebo procedure, and 13.2 percent ofthe patients in the lavage and débridement groups guessedthat they had undergone a placebo procedure.
The primary end point was pain in the study knee 24 months afterthe intervention, as assessed by a 12-item self-reported Knee-SpecificPain Scale (KSPS) created for this study (see Supplementary Appendix 1,available with the full text of this article athttp://www.nejm.org). Scores on this scale range from 0 to 100,with higher scores indicating more severe pain. In addition,to ensure our ability to detect any benefit, we also used fivesecondary efficacy end points: two additional assessments ofpain and three assessments of function at all time points. Arthritispain in general (i.e., not specifically in the study knee) wasassessed by means of the four-item pain subscale of the ArthritisImpact Measurement Scales (AIMS2-P).21,22 Higher scores on thissubscale indicate more severe pain. Body pain (i.e., not necessarilyfrom arthritis and not necessarily in the knee) was assessedwith the 2-item pain subscale of the Medical Outcomes Study36-item Short-Form General Health Survey (SF-36-P).23,24 Higherscores on this subscale indicate less severe pain. The AIMS2-Pand the SF-36-P scores were transformed into scores on a scalefrom 0 to 100.
Two self-reported measures of physical function were used: the5-item walking–bending subscale from the AIMS2 (AIMS2-WB,transformed into scores on a scale from 0 to 100, with higherscores indicating more limited function21,22) and the 10-itemphysical-function subscale from the SF-36 (SF-36-PF, transformedinto scores on a scale from 0 to 100, with higher scores indicatingbetter function23,24). As an objective measure, we devised thePhysical Functioning Scale (PFS) to record the amount of timein seconds that a patient required to walk 30 m (100 ft) andto climb up and down a flight of stairs as quickly as possible.Longer times indicate poorer functioning.
All six outcome scales had good reliability. The median Cronbach'salpha (according to analyses of data from eight time pointsfor all scales) exceeded 0.80. Results for all the outcome measuresat all the time points that are not reported here are summarizedin Supplementary Appendix 2, available with the full text ofthis article at http://www.nejm.org.
Statistical Analysis
Our pilot study indicated that it would be feasible to recruit60 patients per year. The trial was designed to have 90 percentpower, with a two-sided type I error of 0.04, to detect a moderateeffect size (0.55) between the placebo group and the combinedarthroscopic-treatment groups in terms of body pain as measuredby the SF-36-P at two years, with an enrollment of 180 patientsand 16 or fewer lost to follow-up (i.e., 164 or more completingthe two-year follow-up). The primary hypothesis was that thepatients in two arthroscopic-intervention groups combined wouldreport the same amount of knee pain at two years as the patientsassigned to the placebo group. All statistical tests comparedthe treatment groups in terms of the values at each visit ratherthan analyzing the changes from base line. (Scores for thesechanges ["change scores"] were analyzed, with results that didnot differ from the results presented here.) The data and safetymonitoring board reviewed interim data 15 months and 24 monthsafter enrollment began, using the Haybittle–Peto group-sequentialmethod, with stopping boundaries of P=0.001 for the two interimanalyses.25,26 All reported P values are two-sided and havenot been adjusted for multiple comparisons.
Our prespecified analytic strategy was to test, at all timepoints, for the superiority of the arthroscopic procedures overthe placebo procedure. Lacking evidence of superiority, we testedfor evidence that the arthroscopic procedures were equivalent27,28,29to the placebo procedure by determining the extent to whichthe study was powered to reject the hypothesis that the arthroscopictreatments caused a small but clinically important improvement(the "minimal important difference"). The minimal importantdifference for a scale is the smallest change score associatedwith a patient's perception of a change in health status,30but it can vary somewhat according to the method of calculationand the study sample.31,32 Minimal important differences foreach of the six study scales were calculated on the basis ofthe trial data by two different methods: the change ratingsof patients (their scores on a single-item scale that askedpatients if their condition was the same, somewhat better [orworse], or much better [or worse] than before surgery) and thestandard error of measurement (the SD of the instrument multipliedby the square root of one minus its reliability coefficient).30,31,32Estimates were also obtained from the literature.31,32,33 Foreach scale, we tested the hypothesis that the placebo procedurewas equivalent to the arthroscopic procedures, using as theminimal important difference the midpoint of the range of theminimal important differences reported in the literature orcalculated on the basis of our data. If the 95 percent confidenceinterval around the estimated size of the effect does not includethe minimal important difference, one can reject the hypothesisthat the arthroscopic procedures have a small but clinicallyimportant benefit.27
Results
A total of 180 patients underwent randomization; 60 were assignedto the placebo group, 61 to the lavage group, and 59 to thedébridement group. Base-line characteristics were similarin the three study groups (Table 1).
Table 1. Base-Line Characteristics of the Randomized Patients.
At no point did either arthroscopic-intervention group have greater pain relief than the placebo group(Figure 1, Table 2,and Supplementary Appendix 2). For example, there was nodifference in knee pain between the placebo group and eitherthe lavage group or the débridement group at one year(mean [±SD] KSPS scores, 48.9±21.9, 54.8±19.8,and 51.7±22.4, respectively; P=0.14 for the comparisonwith the lavage group, and P=0.51 for the comparison with thedébridement group) or at two years (mean KSPS scores,51.6±23.7, 53.7±23.7, and 51.4±23.2, respectively;P=0.64 and P=0.96, respectively). Similarly, there was no significantdifference in arthritis pain between the placebo group and thelavage group or the débridement group at one or two years(Table 2).
Figure 1. Mean Values (and 95 Percent Confidence Intervals) on the Knee-Specific Pain Scale.
Assessments were made before the procedure and 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months after the procedure. Higher scores indicate more severe pain.
Table 2. Scores on the Pain Subscale of the Arthritis Impact Measurement Scales.
Furthermore, at no time point did either arthroscopic-interventiongroup have significantly greater improvement in function thanthe placebo group (Figure 2, Table 3, and Supplementary Appendix 2).For example, there was no significant difference betweenthe placebo group and either the lavage group or the débridementgroup in the self-reported ability to walk and bend at one year(mean AIMS2-WB scores, 49.4±25.5, 49.6±29.1, and56.4±28.4, respectively; P=0.98 for the comparison withthe lavage group, and P=0.19 for the comparison with the débridementgroup) or at two years (mean AIMS2-WB score, 53.8±27.5,51.1±28.3, and 56.4±29.4, respectively; P=0.61and P=0.64, respectively). Indeed, objectively measured walkingand stair climbing were poorer in the débridement groupthan in the placebo group at two weeks (mean PFS score, 56.0±21.8vs. 48.3±13.4; P=0.02) and one year (mean PFS score,52.5±20.3 vs. 45.6±10.2; P=0.04) and showed atrend toward worse functioning at two years (mean PFS score,52.6±16.4 vs. 47.7±12.0; P=0.11) (Table 3).
Figure 2. Mean Values (and 95 Percent Confidence Intervals) on the Walking–Bending Subscale of the Arthritis Impact Measurement Scales (AIMS2).
Assessments were made before the procedure and 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months after the procedure. Higher scores indicate poorer functioning.
Table 3. Scores on the Physical Functioning Scale.
Lacking evidence of the superiority of the arthroscopic treatmentsover the placebo procedure in relieving pain or improving function,we considered whether the 95 percent confidence intervals forthe differences in outcome between each arthroscopic procedureand the placebo procedure included clinically important differences.The minimal important differences used for this evaluation wereas follows: a difference of 13.5 points on the KSPS, 10.0 onthe AIMS2-P, 11.8 on the SF-36-P, 12.8 on the AIMS2-WB, 11.3on the SF-36-PF, and 4.5 on the PFS. At almost all time pointsduring follow-up (72 of 84 comparisons), the confidence intervalsexcluded these minimal important differences.
Discussion
This study provides strong evidence that arthroscopic lavagewith or without débridement is not better than and appearsto be equivalent to a placebo procedure in improving knee painand self-reported function. Indeed, at some points during follow-up,objective function was significantly worse in the débridementgroup than in the placebo group.
Arthroscopy is the most commonly performed type of orthopedicsurgery, and the knee is by far the most common joint on whichit is performed.1 Numerous uncontrolled, retrospective caseseries have reported substantial pain relief after arthroscopiclavage or arthroscopic débridement for osteoarthritisof the knee.2,3,4,5,6,7,8,9,10,11,12,13,14,15,16 In the onlyprevious double-blind, randomized, controlled trial of kneearthroscopy of which we are aware,34 patients with minimal osteoarthritisas assessed by radiography were assigned to undergo arthroscopiclavage with either 3000 ml of fluid (treatment) or 250 ml offluid (control) and were followed for one year. Both the treatmentand the control groups reported improvement in function at 12months, and although the report interprets the study as havingproved the efficacy of lavage, there was no statistically significantdifference between the groups in terms of the primary outcomeat any point during follow-up.
To explain the improvement that has been reported after theseprocedures, some have proposed that the fluid that is flushedthrough the knee during arthroscopy cleanses the knee of painfuldebris and inflammatory enzymes.4,6,9,15,16,34 Others have suggestedthat the improvement is due to the removal of flaps of articularcartilage, torn meniscal fragments, hypertrophied synovium,and loose debris.2,3,4,5,6,7,8,9,10,11,12,13,14 However, ourstudy found that outcomes after arthroscopic treatment are nobetter than those after a placebo procedure. This lack of differencesuggests that the improvement is not due to any intrinsic efficacyof the procedures. Although patients in the placebo groups ofrandomized trials frequently have improvement, it may be attributableto either the natural history of the condition or some independenteffect of the placebo.
Because we found no evidence that lavage or débridementis superior to a placebo procedure, the question arises whetherthese arthroscopic procedures could have small but clinicallyimportant benefits that we missed because of our limited samplesize. To evaluate this possibility, we determined the size ofthe clinical benefit that the trial was able to rule out, usingthe minimal important difference for each of our scales. Becauseestimates of minimal important differences based on differentsamples and different methods do not yield the same values,we used the midpoint of the range of available minimal importantdifferences in order to test our hypothesis about the equivalenceof the three procedures. For the great majority of comparisons,the 95 percent confidence intervals did not contain the minimalimportant difference, indicating that there was not a clinicallyimportant improvement that the study had simply failed to detect.
One surgeon performed all the procedures in this study. Consequently,his technical proficiency is critical to the generalizabilityof our findings. Our study surgeon is board-certified, is fellowship-trainedin arthroscopy and sports medicine, and has been in practicefor 10 years in an academic medical center. He is currentlythe orthopedic surgeon for a National Basketball Associationteam and was the physician for the men's and women's U.S. Olympicbasketball teams in 1996.
The principal limitation of this study is that our participantsmay not be representative of all candidates for arthroscopictreatment of osteoarthritis of the knee. Almost all participantswere men, because the study was conducted at a Veterans Affairsmedical center. We do not know whether our findings may be generalizedto women, although uncontrolled studies do not indicate thatthere are differences between the sexes in responses to arthroscopicprocedures.8,10,13 A selection bias might have been introducedby the fact that 44 percent of the eligible patients declinedto participate in the study. We believe this high rate of refusalto participate resulted from the fact that all patients knewthey had a one-in-three chance of undergoing a placebo procedure.Patients who agreed to participate might have been so sure thatan arthroscopic procedure would help that they were willingto take a one-in-three chance of undergoing the placebo procedure.Such patients might have had higher expectations of benefitor been more susceptible to a placebo effect than those whochose not to participate.
If the efficacy of arthroscopic lavage or débridementin patients with osteoarthritis of the knee is no greater thanthat of placebo surgery, the billions of dollars spent on suchprocedures annually might be put to better use. This study hasalso shown the great potential for a placebo effect with surgery,although it is unclear whether this effect is due solely tothe natural history of the condition or whether there is someindependent effect. Researchers should reconsider the best waysof testing the efficacy of surgical procedures performed purelyfor the improvement of symptoms. In the debate about placebo-controlledtrials of surgery, the critical ethical considerations surroundthe choice of the placebo. Finally, health care researchersshould not underestimate the placebo effect, regardless of itsmechanism.35
Supported by a grant from the Department of Veterans Affairs.
Source Information
From the Houston Veterans Affairs Medical Center (J.B.M., K.O., N.J.P., T.J.M., D.H.K., C.M.A., N.P.W.); the Department of Orthopedic Surgery (J.B.M.), the Department of Medicine, Section of Health Services Research (K.O., N.J.P., T.J.M., C.M.A., N.P.W.), and the Center for Medical Ethics and Health Policy (B.A.B.), Baylor College of Medicine; and International Survey Research (D.H.K.) — all in Houston; and the Laguna Honda Hospital, San Francisco (J.C.H.).
Address reprint requests to Dr. Wray at the Section of Health Services Research, Baylor College of Medicine, 2002 Holcombe Blvd. (M.R. 152), Houston, TX 77030, or at nwray{at}bcm.tmc.edu.
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Arthroscopic Surgery for Osteoarthritis of the Knee
Jackson R. W., Ewing W., Ewing J. W., Chambers K. G., Schulzer M., Blacher R. S., Morse L. J., Wray N. P., Moseley J. B., O'Malley K., Horng S., Miller F. G.
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347:1717-1719, Nov 21, 2002.
Correspondence
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4 on a visual-analogue scale ranging from 0 to 10) despite maximal medical treatment for at least six months, and had not undergone arthroscopy of the knee during the previous two years. 
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