Trial Outcomes & Findings for Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement (NCT NCT01410409)
NCT ID: NCT01410409
Last Updated: 2017-10-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Primary: 12months.
Results posted on
2017-10-16
Participant Flow
Participant milestones
| Measure |
MEDIC
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement
Baseline characteristics by cohort
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Body Mass Index
|
32.0 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
32.0 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)
|
16.0 units on a scale
Interval 10.1 to 21.9
|
32.5 units on a scale
Interval 26.6 to 38.3
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Change in EQ-5D From Baseline
Descriptive index
|
0.115 units on a scale
Interval 0.063 to 0.166
|
0.206 units on a scale
Interval 0.141 to 0.27
|
|
Change in EQ-5D From Baseline
Visual-analogue scale
|
10.2 units on a scale
Interval 4.6 to 15.7
|
15.0 units on a scale
Interval 8.6 to 21.5
|
SECONDARY outcome
Timeframe: Primary: 12months.Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Change in Timed Up & Go (TUG) From Baseline
|
-1.2 sec
Interval -1.8 to -0.6
|
-2.4 sec
Interval -3.1 to -1.6
|
SECONDARY outcome
Timeframe: Primary: 12months.Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Change in 20-meter Walk From Baseline
|
-1.0 sec
Interval -1.5 to -0.4
|
-2.9 sec
Interval -3.8 to -1.9
|
SECONDARY outcome
Timeframe: Primary: 12months.All subscales going from 0 to 100 (worst to best)
Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Change in the Five Subscales of KOOS From Baseline
Pain
|
17.2 units on a scale
Interval 10.4 to 24.1
|
34.8 units on a scale
Interval 28.1 to 41.5
|
|
Change in the Five Subscales of KOOS From Baseline
Symptoms
|
11.4 units on a scale
Interval 4.4 to 18.4
|
26.4 units on a scale
Interval 21.5 to 31.4
|
|
Change in the Five Subscales of KOOS From Baseline
Activities of Daily Living
|
17.6 units on a scale
Interval 11.4 to 23.9
|
30.0 units on a scale
Interval 22.7 to 37.2
|
|
Change in the Five Subscales of KOOS From Baseline
Quality of Life
|
17.8 units on a scale
Interval 11.2 to 24.4
|
38.2 units on a scale
Interval 30.6 to 45.8
|
|
Change in the Five Subscales of KOOS From Baseline
Sports and recreation
|
19.3 units on a scale
Interval 10.8 to 27.7
|
34.5 units on a scale
Interval 27.9 to 41.0
|
SECONDARY outcome
Timeframe: Primary: 12months.Population: Only patients with a BMI equal to or \>25 were included in the analysis
Weight change in kg measured without shoes at the same time of day and on the same scale
Outcome measures
| Measure |
MEDIC
n=43 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=39 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Weight Change in kg From Baseline
|
-2.6 kg
Interval -3.9 to -1.4
|
0.1 kg
Interval -1.5 to 1.7
|
SECONDARY outcome
Timeframe: Baseline and 12months.With possible answers being yes and no
Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Proportion of Users of Pain Medication
Baseline
|
0.58 proportion of participants
Interval 0.44 to 0.71
|
0.67 proportion of participants
Interval 0.53 to 0.79
|
|
Proportion of Users of Pain Medication
12months
|
0.41 proportion of participants
Interval 0.28 to 0.55
|
0.26 proportion of participants
Interval 0.15 to 0.41
|
SECONDARY outcome
Timeframe: Primary: 12monthsAdverse 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
Outcome measures
| Measure |
MEDIC
n=50 Participants
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 Participants
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Serious Adverse Events Related to the Index Knee
|
1 Serious adverse events related to knee
|
8 Serious adverse events related to knee
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3months, 6months, 12months and 24 months.Population: Will be reported in later publications, as it is exploratory outcomes
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 II TM 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.
Outcome measures
Outcome data not reported
Adverse Events
MEDIC
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
MEDIC + TKR
Serious events: 20 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDIC
n=50 participants at risk
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 participants at risk
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain in the opposite knee leading to TKR
|
0.00%
0/50
|
6.0%
3/50 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
melanoma
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumor in the small intestine
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
cerebral thrombosis
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Stiffness requiring brisement forcé
|
2.0%
1/50 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Deep infection in knee joint
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Deep venous thrombosis requiring anticoagulation
|
0.00%
0/50
|
6.0%
3/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
femoral neck fracture
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain leading to spinal fusion
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain with outpouching of the colon
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
hiatal hernia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
coronary thrombosis
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
hospitalization due to suspicion of cerebral thrombosis caused by neurological symptoms in the legs
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
hospitalization due to depression and anxiety
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
atrial fibrillation
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
leukemia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
hospitalization due to retinal detachment
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
trauma to the cranium from a fall leading to hospitalization
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
myelomatosis
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
MEDIC
n=50 participants at risk
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
MEDIC + TKR
n=50 participants at risk
TKR: Surgical treatment with insertion of total knee replacement following standard procedures.
Followed by:
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
Paracetamol: 1 g x 4/day
Burana: 400 mg x 3/day
Pantoprazol: 20mg x 1/day
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.
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.
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).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in index knee
|
42.0%
21/50 • Number of events 21
|
54.0%
27/50 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
Swelling in index knee
|
4.0%
2/50 • Number of events 2
|
16.0%
8/50 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Instability of index knee
|
6.0%
3/50 • Number of events 3
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Decreased range of motion of index knee
|
2.0%
1/50 • Number of events 1
|
12.0%
6/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Joint distortion of index knee
|
4.0%
2/50 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
sensation of the index knee locking up
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Calor and rubor around index knee
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
soft tissue calcification at index knee
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
hospital care due to liquid oozing from the TKR scar
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
superficial infection of TKR knee
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
bleeding from the TKR wound
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
numbness around the TKR scar
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
increased soreness around the TKR knee
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pruritus around the knee
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Social circumstances
serious illness in the family
|
4.0%
2/50 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Social circumstances
lack of motivation/time
|
4.0%
2/50 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
eye surgery
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
impaired balance
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
medication intake resulting in fatigue
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Social circumstances
advised by doctor to reduce the intensity of exercise due to hypertension
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Social circumstances
advised by doctor to exercise only once a week due to a lack of leukocytes
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
neuropathic wound on the foot
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
abscess in the gluteal region
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
pain in the opposite knee
|
4.0%
2/50 • Number of events 2
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pain in the opposite knee with previous TKR
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
pain in the hip
|
4.0%
2/50 • Number of events 2
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
hand/finger surgery/fracture
|
6.0%
3/50 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
painful pes planus
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
sciatic nerve pain
|
4.0%
2/50 • Number of events 2
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
4.0%
2/50 • Number of events 2
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
rib, head and hip pain following two falls
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
short-lasting restless legs
|
2.0%
1/50 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
paresthesia of the foot
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
shoulder surgery due to rupture of m. supraspinatus
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
spinal stenosis
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
lateral ankle pain
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
ankle sprain
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
0.00%
0/50
|
6.0%
3/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
pain in the hamstrings muscles
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
Ankylosing Spondylitis
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
shoulder injury from a fall
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
muscle strain in the upper thigh
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
Musculoskeletal and connective tissue disorders
plantar fasciitis
|
2.0%
1/50 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
low haemoglobin percentage
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Injury, poisoning and procedural complications
abnormal swelling of the whole leg in the days after TKR surgery
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
General disorders
nausea
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
nerve pain
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
tranexamic acid given pre-surgery by mistake (unintended event)
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Injury, poisoning and procedural complications
puncture of the synovial membrane during lateral release
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
mental unstability
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
loss of consciousness leading to a fall
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
lack of skin under the foot resulting in pain and limping
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
increased need of insulin
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Achilles tendinopathy
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
iliotibial band syndrome
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
swelling of the foot
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
arm pain
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
quadriceps strain
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back and hip pain following a fall
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in the hamstrings muscle
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
short-lasting vertigo
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
reduced walking distance
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place