Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement

NCT01410409 | Completed Results

• 1 other identifier: N-20110024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)

  The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.

  Primary: 12months.

Secondary Outcomes (7)

• Change in EQ-5D From Baseline

  Primary: 12months.

• Change in Timed Up & Go (TUG) From Baseline

  Primary: 12months.

• Change in 20-meter Walk From Baseline

  Primary: 12months.

• Change in the Five Subscales of KOOS From Baseline

  Primary: 12months.

• Weight Change in kg From Baseline

  Primary: 12months.

Other Outcomes (1)

• Exploratory Outcomes

  Baseline, 3months, 6months, 12months and 24 months.

Study Arms (3)

MEDIC

ACTIVE COMPARATOR

Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.

Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Other: Insoles

MEDIC + TKR

ACTIVE COMPARATOR

Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.

Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Procedure: TKR; Other: Insoles

Observational Cohort

ACTIVE COMPARATOR

If the patient can be included, but doesn't want to participate in the randomization, the patient is offered to enter into a prospective observational cohort with the same endpoints and the same follow-up as in the randomized study. The participant can then, in consultation with his/her physician, choose whether they would like MEDIC-treatment or TKR in combination with MEDIC-treatment.

Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Procedure: TKR; Other: Insoles

Interventions

Neuromuscular training (NEMEX-TJR) OTHER

60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

Paracetamol DRUG

1 g x 4/day

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

Burana DRUG

400 mg x 3/day for three weeks

Also known as: NSAIDs are chosen in collaboration with the participant.

MEDIC; MEDIC + TKR; Observational Cohort

Pantoprazol DRUG

20mg x 1/day for three weeks

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

Dietary counseling BEHAVIORAL

For participants with a BMI equal to or \>25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

Patient education BEHAVIORAL

The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden.

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

TKR PROCEDURE

Surgical treatment with insertion of total knee replacement following standard procedures.

Also known as: Total Knee Replacement, Knee arthroplasty

MEDIC + TKR; Observational Cohort

Insoles OTHER

The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). The participants will be advised to use the insoles in all shoes.

Also known as: no other names

MEDIC; MEDIC + TKR; Observational Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead
• The Danish Rheumatism Association: collaborator
• Obel Family Foundation: collaborator
• Spar Nord Foundation: collaborator
• The Bevica Foundation: collaborator
• Aalborg University: collaborator
• Association of Danish Physiotherapists: collaborator
• Formthotics: collaborator
• Medical Specialist Heinrich Kopp's Grant: collaborator
• Danish Medical Association: collaborator

Study Sites (3)

Department of Occupational and Physiotherapy, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Farsoe Hospital

Farsø, 9640, Denmark

Location

Vendsyssel Hospital, Frederikshavn

Frederikshavn, 9900, Denmark

Location

Related Publications (14)

• 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.

  PMID: 11156538 BACKGROUND

• 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.

  PMID: 18279766 BACKGROUND

• 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.

  PMID: 14644851 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17719803 BACKGROUND

• 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.

  PMID: 11030685 BACKGROUND

• Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available.

  PMID: 16543327 BACKGROUND

• 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.

  PMID: 26488691 BACKGROUND

• 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.

  PMID: 31948990 DERIVED

• 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.

  PMID: 29723634 DERIVED

• 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.

  PMID: 29369450 DERIVED

• 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.

  PMID: 27029553 DERIVED

• 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.

  PMID: 26304646 DERIVED

• 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.

  PMID: 22571284 DERIVED

Related Links

• Link to the published statistical analysis plan

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acetaminophen; Pantoprazole; Nutrition Assessment; Patient Education as Topic; Arthroplasty, Replacement, Knee; Foot Orthoses

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Søren T. Skou
• Organization: Aalborg University Hospital

sots@rn.dk

+4523708640

Study Officials

• Søren T Skou, PhD-student

  Orthopaedic Research Unit, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Ewa M Roos, PhD

  Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark

  STUDY CHAIR

• Lars Arendt-Nielsen, Dr.Sci.Med.

  Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University

  STUDY CHAIR

• Mogens B Laursen, PhD

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Sten Rasmussen, MD

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Michael S Rathleff, PhD-student

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Ole H Simonsen, Dr.Med.

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 5, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 16, 2017
• Results First Posted: January 27, 2016

Record last verified: 2017-09

Locations

DK (3)