N/A
N=100
Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT01410409 ↗Enrolled (actual)
100
Serious AEs
25.0%
Results posted
Jan 2016
Primary outcome: Primary: Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score) — 16.0; 32.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular training (NEMEX-TJR) (Other); Paracetamol (Drug); Burana (Drug); Pantoprazol (Drug); Dietary counseling (Behavioral); Patient education (Behavioral); TKR (Procedure); Insoles (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Northern Orthopaedic Division, Denmark
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score) |
16.0; 32.5 | — |
| SECONDARY Change in EQ-5D From Baseline |
0.115; 0.206; 10.2; 15.0 | — |
| SECONDARY Change in Timed Up & Go (TUG) From Baseline |
-1.2; -2.4 | — |
| SECONDARY Change in 20-meter Walk From Baseline |
-1.0; -2.9 | — |
| SECONDARY Change in the Five Subscales of KOOS From Baseline |
17.2; 34.8; 11.4; 26.4; 17.6; 30.0 | — |
| SECONDARY Weight Change in kg From Baseline |
-2.6; 0.1 | — |
| SECONDARY Proportion of Users of Pain Medication |
0.58; 0.67; 0.41; 0.26 | — |
| SECONDARY Serious Adverse Events Related to the Index Knee |
1; 8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01410409). 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.