Clinical trial NCT01410409: Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement
Official title: Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee
Treatment Outcome
Time Factors
Arthroplasty, Replacement
Rehabilitation
Combined Modality Therapy
Middle Aged
Aged
Aged, 80 and over
Male
Female
Humans
Analysis of Variance
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: Obel Family Foundation
name: Spar Nord Foundation
name: The Bevica Foundation
name: Aalborg University
name: Association of Danish Physiotherapists
name: Formthotics
name: Medical Specialist Heinrich Kopp's Grant
name: Danish Medical Association
First posted: 2011-08-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).

The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Detailed description: Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee OA should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. If this non-surgical treatment is ineffective surgical treatment, especially surgery with insertion of total knee replacement (TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no studies exist, which examine the effect of surgery with insertion of TKR in addition to the recommended non-surgical treatment of knee OA.

Eligibility criteria: Inclusion Criteria:

* Knee-OA detected by x-ray (Kellgren \& Lawrence grade 2 or greater)
* Considered a candidate for TKR by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

* Bilateral simultaneous TKR
* Revision of prior TKR, unicompartmental knee arthroplasty or high tibial osteotomy
* Rheumatoid arthritis
* Mean VAS \> 60mm on a 0-100mm scale
* Investigator considers that the mental condition of the participant does not allow participation.
* The participant must not be pregnant or plan pregnancy during the study.
* Inability to comply with the protocol;.
* Inadequacy in written and spoken Danish.

Primary outcomes:
measure: Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: Primary: 12months.
Secondary outcomes:
measure: Change in EQ-5D From Baseline
timeFrame: Primary: 12months.
measure: Change in Timed Up & Go (TUG) From Baseline
timeFrame: Primary: 12months.
measure: Change in 20-meter Walk From Baseline
timeFrame: Primary: 12months.
measure: Change in the Five Subscales of KOOS From Baseline
timeFrame: Primary: 12months.
measure: Weight Change in kg From Baseline
timeFrame: Primary: 12months.
measure: Proportion of Users of Pain Medication
timeFrame: Baseline and 12months.
measure: Serious Adverse Events Related to the Index Knee
timeFrame: Primary: 12months
Other outcomes:
measure: Exploratory Outcomes
timeFrame: Baseline, 3months, 6months, 12months and 24 months.
Locations:
city: Aalborg
country: Denmark
facility: Department of Occupational and Physiotherapy, Aalborg University Hospital
city: Farsø
country: Denmark
facility: Farsoe Hospital
city: Frederikshavn
country: Denmark
facility: Vendsyssel Hospital, Frederikshavn
Study officials:
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Søren T Skou, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
name: Ewa M Roos, PhD
role: STUDY_CHAIR
affiliation: Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University
name: Lars Arendt-Nielsen, Dr.Sci.Med.
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Mogens B Laursen, PhD
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, MD
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Michael S Rathleff, PhD-student
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Ole H Simonsen, Dr.Med.
role: STUDY_CHAIR
References:
citation: Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
citation: Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
citation: Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
citation: National Board of Health, Denmark. Referenceprogram for knæartrose. Copenhagen: National Board of Health, Denmark; 2007. [22.02.2010] found at: http://www.sst.dk/publ/Publ2007/PLAN/SfR/Refprg_knaeartrose.pdf
citation: Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
citation: Walker-Bone K, Javaid K, Arden N, Cooper C. Regular review: medical management of osteoarthritis. BMJ. 2000 Oct 14;321(7266):936-40. doi: 10.1136/bmj.321.7266.936. No abstract available.
citation: Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.
citation: Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
citation: Skou ST, Roos E, Laursen M, Arendt-Nielsen L, Rasmussen S, Simonsen O, Ibsen R, Larsen AT, Kjellberg J. Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark. BMJ Open. 2020 Jan 15;10(1):e033495. doi: 10.1136/bmjopen-2019-033495.
citation: Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S, Simonsen O. Total knee replacement and non-surgical treatment of knee osteoarthritis: 2-year outcome from two parallel randomized controlled trials. Osteoarthritis Cartilage. 2018 Sep;26(9):1170-1180. doi: 10.1016/j.joca.2018.04.014. Epub 2018 May 1.
citation: Arendt-Nielsen L, Simonsen O, Laursen MB, Roos EM, Rathleff MS, Rasmussen S, Skou ST. Pain and sensitization after total knee replacement or nonsurgical treatment in patients with knee osteoarthritis: Identifying potential predictors of outcome at 12 months. Eur J Pain. 2018 Jul;22(6):1088-1102. doi: 10.1002/ejp.1193. Epub 2018 Feb 15.
citation: Skou ST, Roos EM, Simonsen O, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S. The effects of total knee replacement and non-surgical treatment on pain sensitization and clinical pain. Eur J Pain. 2016 Nov;20(10):1612-1621. doi: 10.1002/ejp.878. Epub 2016 Mar 31.
citation: Skou ST, Rasmussen S, Simonsen O, Roos EM. Knee Confidence as It Relates to Self-reported and Objective Correlates of Knee Osteoarthritis: A Cross-sectional Study of 220 Patients. J Orthop Sports Phys Ther. 2015 Oct;45(10):765-71. doi: 10.2519/jospt.2015.5864. Epub 2015 Aug 24.
citation: Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen OH, Rasmussen S. Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study). BMC Musculoskelet Disord. 2012 May 9;13:67. doi: 10.1186/1471-2474-13-67.