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Osteoarthritis of the KneeMEDICNCT01410409

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

A study testing Neuromuscular training (NEMEX-TJR), Paracetamol and Burana in people with Osteoarthritis of the Knee, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis of the Knee
What is being tested?
Neuromuscular training (NEMEX-TJR), Paracetamol and Burana
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesDenmark
Study dates
Sep 2011to Mar 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Department of Occupational and Physiotherapy, Aalborg University Hospital

    Aalborg, 9000

  • Farsoe Hospital

    Farsø, 9640

  • Vendsyssel Hospital, Frederikshavn

    Frederikshavn, 9900

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Neuromuscular training (NEMEX-TJR), Paracetamol, Burana, Pantoprazol, Dietary counseling
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
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular training (NEMEX-TJR)Other

    Also called no other names

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

  • ParacetamolDrug

    Also called no other names

    1 g x 4/day

  • BuranaDrug

    Also called NSAIDs are chosen in collaboration with the participant.

    400 mg x 3/day for three weeks

  • PantoprazolDrug

    Also called no other names

    20mg x 1/day for three weeks

  • Dietary counselingBehavioural

    Also called no other names

    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.

  • Patient educationBehavioural

    Also called no other names

    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.

  • TKRProcedure or surgery

    Also called Total Knee Replacement, Knee arthroplasty

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

  • InsolesOther

    Also called no other names

    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.

Study groups in NCT01410409
Study groupRoleWhat they receive
MEDICActive comparatorMedicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Receives: Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Other: Insoles
MEDIC + TKRActive comparatorMedicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Receives: Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Procedure: TKR; Other: Insoles
Observational CohortActive comparatorIf 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.
Receives: Other: Neuromuscular training (NEMEX-TJR); Drug: Paracetamol; Drug: Burana; Drug: Pantoprazol; Behavioral: Dietary counseling; Behavioral: Patient education; Procedure: TKR; Other: Insoles

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Primary: 12months.

Secondary outcomes (7)

  1. Change in EQ-5D From Baseline

    Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description ("Links")

    Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best).

    Measured: Primary: 12months.

  2. Change in Timed Up & Go (TUG) From Baseline

    Measured: Primary: 12months.

  3. Change in 20-meter Walk From Baseline

    Measured: Primary: 12months.

  4. Change in the Five Subscales of KOOS From Baseline

    All subscales going from 0 to 100 (worst to best)

    Measured: Primary: 12months.

  5. Weight Change in kg From Baseline

    Weight change in kg measured without shoes at the same time of day and on the same scale

    Measured: Primary: 12months.

  6. Proportion of Users of Pain Medication

    With possible answers being yes and no

    Measured: Baseline and 12months.

  7. Serious Adverse Events Related to the Index Knee

    Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants

    Measured: Primary: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410409
Sponsor's protocol ID
N-20110024
Acronym
MEDIC
Status last verified
Sep 2017
First submitted
2 Aug 2011
Last updated
16 Oct 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 11156538

  • 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.

    PubMed 18279766

  • 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.

    PubMed 14644851

  • 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

  • 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.

    PubMed 17719803

  • 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.

    PubMed 11030685

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

    PubMed 16543327

  • 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.

    PubMed 26488691

  • 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.

    PubMed 31948990

  • 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.

    PubMed 29723634

  • 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.

    PubMed 29369450

  • 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.

    PubMed 27029553

  • 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.

    PubMed 26304646

  • 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.

    PubMed 22571284

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular training (NEMEX-TJR), Paracetamol and Burana in people with Osteoarthritis of the Knee, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score) (time frame: Primary: 12months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01410409, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.

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