Treatment of Primary and Secondary Osteoarthritis of the Knee [Entered Retrospectively]

Project Summary Title and Description

Title
Treatment of Primary and Secondary Osteoarthritis of the Knee [Entered Retrospectively]
Description
Objectives: Systematic review of outcomes of three treatments for osteoarthritis (OA) of the knee: intra-articular viscosupplementation; oral glucosamine, chondroitin or the combination; and arthroscopic lavage or debridement. Data Sources: We abstracted data from: 42 randomized, controlled trials (RCTs) of viscosupplementation, all but one synthesized among six meta-analyses; 21 RCTs of glucosamine/chondroitin, 16 synthesized among 6 meta-analyses; and 23 articles on arthroscopy. The search included foreign-language studies and relevant conference proceedings. Review Methods: The review methods were defined prospectively in a written protocol. We sought systematic reviews, meta-analyses, and RCTs published in full or in abstract. Where randomized trials were few, we sought other study designs. We independently assessed the quality of all primary studies. Results: Viscosupplementation trials generally report positive effects on pain and function scores compared to placebo, but the evidence on clinical benefit is uncertain, due to variable trial quality, potential publication bias, and unclear clinical significance of the changes reported. The Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), a large (n=1,583), high- quality, National Institutes of Health-funded, multicenter RCT showed no significant difference compared to placebo. Glucosamine sulfate has been reported to be more effective than glucosamine hydrochloride, which was used in GAIT, but the evidence is not sufficient to draw conclusions. Clinical studies of glucosamine effect on glucose metabolism are short term, or if longer (e.g., 3 years), excluded patients with metabolic disorders. The best available evidence for arthroscopy, a single sham-controlled RCT (n=180), showed that arthroscopic lavage with or without debridement was equivalent to placebo. The main limitations of this trial are the use of a single surgeon and enrollment of patients at a single Veterans Affairs Medical Center. No studies reported separately on patients with secondary OA of the knee. The only comparative study was an underpowered, poor-quality trial comparing viscosupplementation to arthroscopy with debridement. Conclusions: Osteoarthritis of the knee is a common condition. The three interventions reviewed in this report are widely used in the treatment of OA of the knee, yet the best available evidence does not clearly demonstrate clinical benefit. Uncertainty regarding clinical benefit can be resolved only by rigorous, multicenter RCTs. In addition, given the public health impact of OA of the knee, research on new approaches to prevention and treatment should be given high priority.
Attribution
N/A
Authors of Report
N/A
Methodology description
The review methods were defined prospectively in a written protocol. A technical expert panel provided consultation. The draft report was also reviewed by other experts and stakeholders. We sought systematic reviews, meta-analyses, and RCTs published in full or in abstract that reported on one or more of the interventions among patients with primary or secondary osteoarthritis of the knee; and reported at least one outcome of interest. Primary outcomes were pain, function, quality of life and adverse effects. Our search had no language restrictions and used these electronic databases: • MEDLINE® (through March 29, 2007) • EMBASE (through March 16, 2006) • Cochrane Controlled Trials Register (through November 27, 2006). EMBASE was updated with abbreviated searches through November 27, 2006. Additional sources were 2004–2006 conference proceedings of the American Association of Orthopedic Surgeons (AAOS), American College of Rheumatology (ACR) and the Osteoarthritis Research Society International (OARSI). Product inserts of U.S.-marketed viscosupplements were consulted. There were few RCTs on arthroscopy or comparative outcomes, so we also sought nonrandomized comparative trials and, for arthroscopy, administrative database analyses and case series (n>50). Because several comprehensive systematic reviews with meta-analyses on viscosupplementation and glucosamine/chondroitin had been published, we focused on detailed review of existing meta-analyses, supplemented by primary studies where necessary. Of 1,842 citations, 451 articles were retrieved and 98 selected for inclusion: • Six meta-analyses (N=41 trials) and one additional trial of viscosupplementation • Six meta-analyses (N=16 trials) and five additional trials of glucosamine/chondroitin • 23 articles on arthroscopy. A single reviewer screened citations for article retrieval; citations judged as uncertain were reviewed by a second reviewer. The same procedure was used to select articles for inclusion in the review. A single reviewer performed data abstraction and a second reviewed the evidence tables for accuracy. However, study quality was appraised by dual independent review. All disagreements were resolved by consensus. The quality of RCTs and quasi-experimental studies were assessed using the general approach developed by the U.S. Preventive Services Task Force (Harris, Helfand, Woolf, et al. 2001). Assessment of the quality of systematic reviews and meta-analyses were guided by a quality rating method reported by Oxman and Guyatt (1991). The framework proposed by Carey and Boden (2003) was used to assess the quality of case series.
PROSPERO
N/A
DOI
10.7301/Z0D798BD
Notes
This systematic review of the literature will address the following key questions regarding managing patients with OA of the knee with three interventions: intra-articular injections of viscosupplements; oral glucosamine and chondroitin; and, arthroscopic lavage and debridement. 1. What are the clinical effectiveness and harms of each intervention in patients with primary OA of the knee? 2. What are the clinical effectiveness and harms of each intervention in patients with secondary OA of the knee? 3. How do the short-term and long-term outcomes of each intervention differ by the following subpopulations: age, race/ethnicity, gender, primary or secondary OA, disease severity and duration, weight (body mass index), and prior treatments? 4. How do the short-term and long-term outcomes of each intervention compare for the treatment of primary OA of the knee; and secondary OA of the knee? *** The systematic review data of this published project was retrospectively imported into SRDR by the Brown EPC on behalf of the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center and the Agency for Healthcare Research and Quality (AHRQ). For access to the full report available on the AHRQ website, follow this link: http://archive.ahrq.gov/downloads/pub/evidence/pdf/oaknee/oaknee.pdf ***
Funding Source
The Agency for Healthcare Research and Quality (AHRQ)

Key Questions

1. Key Question 1 - Arthroscopy Case Series
2. Key Question 2 - Randomized Studies of Arthroscopic Lavage/Debridement
3. Key Question 3 - Placebo-Controlled Randomized Trials of Intraarticular Viscosupplements Injections for Knee Osteoarthiritis
4. Key Question 4 - General Comparison of Glucosamine and Chondroitin Meta-Analyses in Knee Osteoarthiritis
5. Key Question 5 - Glucosamine/Chondroitin - RCT Sample Selection

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
Arthroscopic débridement for osteoarthritis of the knee.2006
Arthroscopic washout of the knee--a 5-year survival analysis.2004
Arthroscopic debridement of the osteoarthritic knee under local anaesthesia.2004
Effect of arthroscopic débridement for osteoarthritis of the knee on health-related quality of life.2003
The results of arthroscopic lavage and debridement of osteoarthritic knees based on the severity of degeneration: a 4- to 6-year symptomatic follow-up.2003
The value of knee arthroscopy in patients with severe radiological osteoarthritis.2002
Short-term benefit of arthroscopic washout in degenerative arthritis of the knee.2001
Arthroscopic debridement for osteoarthritis of the knee: predictors of patient satisfaction.1999
Debridement arthroscopy. 10-year followup.1999
Arthroscopic debridement of knee joint arthritis: effect of advancing articular degeneration.1997
Arthroscopic surgery of the knee in the geriatric patient.1995
A prospective review of arthroscopic debridement for degenerative joint disease of the knee.1991
Arthroscopic débridement of the knee for osteoarthrosis.1991
Arthroscopic management of the degenerative knee.1991
Arthroscopy update #6. Arthroscopy in the osteoarthritic knee. Long-term follow-up.1990
The arthroscopic treatment of unicompartmental gonarthrosis: a five-year follow-up study of abrasion arthroplasty plus arthroscopic debridement and arthroscopic debridement alone.1989
Arthroscopic debridement for degenerative knee joint disease.1981
Arthroscopic lavage and debridement for osteoarthritis of the knee.1992
A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee.1993
Short-term effects of knee washout for osteoarthritis.-- Not Found --
Articular debridement versus washout for degeneration of the medial femoral condyle. A five-year study.
Effects of joint lavage and steroid injection in patients with osteoarthritis of the knee: results of a multicenter, randomized, controlled trial.1999
Visually-guided irrigation in patients with early knee osteoarthritis: a multicenter randomized, controlled trial.2000
A randomized placebo-controlled trial of arthroscopic lavage versus lavage plus intra-articular corticosteroids in the management of symptomatic osteoarthritis of the knee.2003
Assessment of the efficacy of joint lavage versus joint lavage plus corticoids in patients with osteoarthritis of the knee.
Intraarticular sodium hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. Hyalgan Study Group.1998
Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee.2004
Controlled single- blind trial of intra-articularly injected hyaluronic acid (Hyalgan®) in osteoarthritis of the knee
Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. ORTHOVISC Study Group.2001
Treatment of painful osteoarthritis of the knee with hyaluronic acid. Results of a multicenter Asian study.2001
The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion
Double-blind randomized trial of intra-articular (I/A) hyaluronate in the treatment of osteoarthritis of the knee
NR
Intra-articular hyaluronic acid in osteoarthritis of the knee: an investigation into mechanisms of action.1994
Intraarticular injections of hyaluronan in patients with cartilage abnormalities and knee pain. A one-year double-blind, placebo-controlled study.1994
A double blind, randomized, multicenter, parallel group study of the effectiveness and tolerance of intraarticular hyaluronan in osteoarthritis of the knee.2004
A double-blind, placebo- controlled comparison of hylan G-F 20 against diclofenac in knee osteoarthritis.
Clinical trial of intra-articular injection of sodium hyaluronate in patients with osteoarthritis of the knee.1988
High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a 1 year placebo-controlled trial.1993
Intra-articular hyaluronic acid in the treatment osteoarthritis of the knee: A short term study
NR
Intra-articular treatment with sodium hyaluronate in gonarthrosis: a controlled clinical trial versus placebo.1987
Clinical trial of intra- articular injection of hyaluronic acid in patients with osteoarthritis of the knee
Intraarticular injections of 750 kD hyaluronan in the treatment of osteoarthritis: a randomised single centre double-blind placebo-controlled trial of 91 patients demonstrating lack of efficacy
NR
Hyaluronic acid in the treatment of osteoarthritis of the knee.1999
A one-year, randomised, placebo (saline) controlled clinical trial of 500-730 kDa sodium hyaluronate (Hyalgan) on the radiological change in osteoarthritis of the knee.-- Not Found --
Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study.2002
A prospective randomised controlled clinical trial comparing the efficacy of different molecular weight hyaluronan solutions in the treatment of knee osteoarthritis.2006
Intra-articular hyaluronan injections in the treatment of osteoarthritis of the knee: a randomised, double blind, placebo controlled multicentre trial. Hyaluronan Multicentre Trial Group.1996
Efficacy and safety of intra-articular hylan G-F 20 (Synvisc), a viscoelastic derivative of hyaluronan, in patients with osteoarthritis of the knee
Intra- articular high molecular weight hyaluronan (Orthovisc(R)) is effective in the treatment of pain of knee osteoarthritis
Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled clinical trial.2002
Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis.2004
Intra-articular sodium hyaluronate in osteoarthritis of the knee: a multicenter, double-blind study.1993
A comparative study of the efficacy and safety of hyaluronan viscosupplements and placebo in patients with symptomatic and arthroscopy- verified cartilage pathology
A randomized, placebo (PL) and no-intervention (NI) controlled trial of intra-articular (IA) 1 percent sodium hyaluronate (HA) in the treatment of knee osteoarthritis (OA)
Viscosupplementation of osteoarthritic knees with hylan: a treatment schedule study
Does hyaluronan affect inflammatory cytokines in knee osteoarthritis?2005
Clinical evaluation of high molecular weight sodium hyaluronate (SPH) on osteoarthritis of the knee—a multi-center well controlled comparative study
Clinical evaluation of sodium hyaluronate in the treatment of osteoarthritis of the knee.1983
Intra-articular hyaluronan injections for the treatment of osteoarthritis of the knee: a randomized, double blind, placebo controlled study.-- Not Found --
Treatment of knee osteoarthritis in Asian population with an intra-articular hyaluronan of MW500-730 KDa
NR
Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee.-- Not Found --
The double-blind test of sodium hyaluronate (ARTZ) on osteoarthritis knee.1997
NR
Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials.2007
Glucosamine therapy for treating osteoarthritis.2005
Glucosamine long-term treatment and the progression of knee osteoarthritis: systematic review of randomized controlled trials.2005
Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis.2003
A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis.2000
Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis.2000
Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator.
Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial.2005
Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo.2004
Efficacy of a combination of FCHG49 glucosamine hydrochloride, TRH122 low molecular weight sodium chondroitin sulfate and manganese ascorbate in the management of knee osteoarthritis.2000

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