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Completed

NCT Number: NCT01410409

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Occupational and Physiotherapy, Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: no other names

Paracetamol

Drug

1 g x 4/day

Other names: no other names

Burana

Drug

400 mg x 3/day for three weeks

Other names: NSAIDs are chosen in collaboration with the participant.

Pantoprazol

Drug

20mg x 1/day for three weeks

Other names: no other names

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.

Other names: no other names

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.

Other names: no other names

TKR

Procedure

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

Other names: Total Knee Replacement, Knee arthroplasty

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.

Other names: no other names

Primary outcomes

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

    Time frame: Primary: 12months.

    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.

Secondary outcomes

  1. Change in EQ-5D From Baseline

    Time frame: Primary: 12months.

    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).

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

    Time frame: Primary: 12months.

  3. Change in 20-meter Walk From Baseline

    Time frame: Primary: 12months.

  4. Change in the Five Subscales of KOOS From Baseline

    Time frame: Primary: 12months.

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

  5. Weight Change in kg From Baseline

    Time frame: Primary: 12months.

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

  6. Proportion of Users of Pain Medication

    Time frame: Baseline and 12months.

    With possible answers being yes and no

  7. Serious Adverse Events Related to the Index Knee

    Time frame: Primary: 12months

    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

Other outcomes

  1. Exploratory Outcomes

    Time frame: Baseline, 3months, 6months, 12months and 24 months.

    • Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.
    • Number of sites with pain in the previous 24 hours shaded on a region-divided body chart
    • Pain location and type assessed using the Knee Pain Map.
    • Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)
    • Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.
    • Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.

    Further exploratory objectives may be added later on.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Aalborg University
  • Association of Danish Physiotherapists
  • Danish Medical Association
  • Formthotics
  • Medical Specialist Heinrich Kopp's Grant
  • Obel Family Foundation
  • Spar Nord Foundation
  • The Bevica Foundation
  • The Danish Rheumatism Association

Registry information

Official study 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

Acronym: MEDIC

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2011
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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