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
Overview
- Phase
- Not Applicable
- Intervention
- Neuromuscular training (NEMEX-TJR)
- Conditions
- Osteoarthritis of the Knee
- Sponsor
- Northern Orthopaedic Division, Denmark
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Arms & Interventions
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Neuromuscular training (NEMEX-TJR)
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Paracetamol
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Burana
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Pantoprazol
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Dietary counseling
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Patient education
MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
Intervention: Insoles
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Neuromuscular training (NEMEX-TJR)
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Paracetamol
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Burana
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Pantoprazol
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Dietary counseling
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Patient education
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: TKR
MEDIC + TKR
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement.
Intervention: Insoles
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.
Intervention: Neuromuscular training (NEMEX-TJR)
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.
Intervention: Paracetamol
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.
Intervention: Burana
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.
Intervention: Pantoprazol
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.
Intervention: Dietary counseling
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.
Intervention: Patient education
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.
Intervention: TKR
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.
Intervention: Insoles
Outcomes
Primary Outcomes
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
- Change in Timed Up & Go (TUG) From Baseline(Primary: 12months.)
- Change in the Five Subscales of KOOS From Baseline(Primary: 12months.)
- Change in 20-meter Walk From Baseline(Primary: 12months.)
- Weight Change in kg From Baseline(Primary: 12months.)
- Change in EQ-5D From Baseline(Primary: 12months.)
- Proportion of Users of Pain Medication(Baseline and 12months.)
- Serious Adverse Events Related to the Index Knee(Primary: 12months)