Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement (MEDIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Danish Rheumatism Association
Obel Family Foundation
Spar Nord Foundation
The Bevica Foundation
Aalborg University
Association of Danish Physiotherapists
Formthotics
Medical Specialist Heinrich Kopp's Grant
The Danish Medical Association Research Fund.
Information provided by (Responsible Party):
Søren Thorgaard Skou, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01410409
First received: August 2, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Osteoarthritis of the Knee
Other: Neuromuscular training (NEMEX-TJR)
Drug: Paracetamol
Drug: Burana
Drug: Pantoprazol
Behavioral: Dietary counseling
Behavioral: Patient education
Procedure: TKR
Other: Insoles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • KOOS4 (Knee injury and Osteoarthritis Outcome Score) [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • EQ-5D [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    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")

  • Timed Up & Go (TUG) [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • 20-meter walk [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • The five subscales of KOOS [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months. ] [ Designated as safety issue: No ]
  • Weight change in percent [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    Weight change in percent measured without shoes at the same time of day and on the same scale

  • Usage of pain killers (yes/no), number of daily paracetamols (1g) and ibuprofen (400mg) and other NSAIDs. [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Exploratory outcomes [ Time Frame: Baseline, 3months, 6months, 12months and 24 months. ] [ Designated as safety issue: No ]
    1. Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.
    2. Number of sites with pain in the previous 24 hours shaded on a region-divided body chart
    3. Pain location and type assessed using the Knee Pain Map.
    4. 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 IITM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)
    5. 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.
    6. 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.



Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Other: Neuromuscular training (NEMEX-TJR)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Other Name: no other names
Drug: Paracetamol
1 g x 4/day
Other Name: no other names
Drug: Burana
400 mg x 3/day for three weeks
Other Name: NSAIDs are chosen in collaboration with the participant.
Drug: Pantoprazol
20mg x 1/day for three weeks
Other Name: no other names
Behavioral: Dietary counseling
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 Name: no other names
Behavioral: Patient education
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 Name: no other names
Other: Insoles

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 Name: no other names
Active Comparator: MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Other: Neuromuscular training (NEMEX-TJR)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Other Name: no other names
Drug: Paracetamol
1 g x 4/day
Other Name: no other names
Drug: Burana
400 mg x 3/day for three weeks
Other Name: NSAIDs are chosen in collaboration with the participant.
Drug: Pantoprazol
20mg x 1/day for three weeks
Other Name: no other names
Behavioral: Dietary counseling
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 Name: no other names
Behavioral: Patient education
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 Name: no other names
Procedure: TKR
Surgical treatment with insertion of total knee replacement following standard procedures.
Other Names:
  • Total Knee Replacement
  • Knee arthroplasty
Other: Insoles

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 Name: no other names
Active Comparator: Observational Cohort
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)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Other Name: no other names
Drug: Paracetamol
1 g x 4/day
Other Name: no other names
Drug: Burana
400 mg x 3/day for three weeks
Other Name: NSAIDs are chosen in collaboration with the participant.
Drug: Pantoprazol
20mg x 1/day for three weeks
Other Name: no other names
Behavioral: Dietary counseling
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 Name: no other names
Behavioral: Patient education
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 Name: no other names
Procedure: TKR
Surgical treatment with insertion of total knee replacement following standard procedures.
Other Names:
  • Total Knee Replacement
  • Knee arthroplasty
Other: Insoles

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 Name: no other names

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410409

Locations
Denmark
Department of Occupational and Physiotherapy, Aalborg University Hospital
Aalborg, Denmark, 9000
Farsoe Hospital
Farsø, Denmark, 9640
Vendsyssel Hospital, Frederikshavn
Frederikshavn, Denmark, 9900
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
The Danish Rheumatism Association
Obel Family Foundation
Spar Nord Foundation
The Bevica Foundation
Aalborg University
Association of Danish Physiotherapists
Formthotics
Medical Specialist Heinrich Kopp's Grant
The Danish Medical Association Research Fund.
Investigators
Principal Investigator: Søren T Skou, PhD-student Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Study Chair: 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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Søren Thorgaard Skou, MSc, ph.d. student, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01410409     History of Changes
Other Study ID Numbers: N-20110024
Study First Received: August 2, 2011
Last Updated: August 6, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014