N/A
N=100
Structured Non-operative Treatment of Knee Osteoarthritis
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT01535001 ↗Enrolled (actual)
100
Serious AEs
25.0%
Results posted
Jan 2016
Primary outcome: Primary: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) — 18.2; 7.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular training (NEMEX-TJR) (Other); Information (Behavioral); Paracetamol (Drug); Burana (Drug); Pantoprazole (Drug); Dietary counseling (Behavioral); Patient education (Behavioral); Insoles (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northern Orthopaedic Division, Denmark
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score) |
18.2; 7.1 | — |
| SECONDARY Change From Baseline in EQ-5D |
0.140; 0.075; 5.3; 7.2 | — |
| SECONDARY Change From Baseline in 20-meter Walk |
-1.2; -0.6 | — |
| SECONDARY Change in the Five KOOS Subscale Scores From Baseline |
18.7; 9.3; 16.3; 7.7; 18.7; 5.9 | — |
| SECONDARY Weight Change in kg From Baseline |
-2.4; -2.4 | — |
| SECONDARY Proportion of Users of Pain Medication |
0.64; 0.56; 0.39; 0.57 | — |
| SECONDARY Number of Serious Adverse Events Reported at Index Knee |
13; 24 | — |
| SECONDARY Change From Baseline in Time From the Timed Up and Go |
-1.4; -1.1 | — |
Summary
The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.
The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment 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.
Eligibility Criteria
Inclusion Criteria
- Knee-OA detected by x-ray (Kellgren & Lawrence grade 1 or greater)
- KOOS4 of ≤ 75
- Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
- The participant is > 18 years of age.
- The participant can provide relevant and adequate, informed consent.
Exclusion Criteria
- Prior TKA ipsilateral
- Rheumatoid arthritis
- Mean VAS > 60mm the last week on a 0-100mm scale
- Possible pregnancy or planning pregnancy;
- Inability to comply with the protocol;
- Inadequacy in written and spoken Danish.
Data sourced from ClinicalTrials.gov (NCT01535001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.