The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.
Primary Purpose
Knee Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.
Exclusion Criteria:
- Patients who do not understand and talk the Swedish language
- Patients with dementia
- Revision surgery of the knee
- Unicompartmentmental knee replacement
Sites / Locations
- Region Skane, VO ortopedi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise with a "peanut ball".
Exercise without "peanut ball"
Arm Description
The rehabilitation program consists of mobility- and functional training exercises with a "peanut ball".
The rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball".
Outcomes
Primary Outcome Measures
Visual analogue scale (VAS) (0-100)
The scale is from 0-100 and a higher value is associated with more pain. 0:no pain and 100: most possible pain.
Secondary Outcome Measures
Range of movement
The range of movement in the knee is measured with a goniometer. The range of movement may be between 0 degree to 145 degree. A higher degree is better.
Forgotten Joint Score (FJS)
Is a questionnaire of the patients awareness of their knee. Minimum score:0 (worse outcome), maximum score 100 (best outcome)
Knee injury and Osteoarthritis Outcome Score (KOOS-12)
Is a questionnaire of knee related function an quality of life. It consists of three parts: pain (4 items), function (4 items) and knee-specific quality of life (4 items). KOOS-12; in pain sub-item; In the sub-item of walking on a flat ground, going up and down stairs, sitting-reaching, function and daily life; There are patient-specific questions in the sub-item of quality of life, sitting up, standing, getting in and out of the car, turning the affected knee. The total scores obtained from the items in the KOOS-12 scale are calculated and the average of the total score is taken from the three sub-dimensions. If any of the three sub-item scores are missing, the average score cannot be calculated.
30 second sit to stand test
A test to evaluate leg strength and endurance. The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).
Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)
Is a generic questionnaire about health related quality of life, 0-100, 0: The worst health you can imagine", 100: "the best health you can imagine". Patients are asked to indicate how your health is today and to write the number in an adoining box.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05137834
Brief Title
The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.
Official Title
The Effect of Postoperative Rehabilitation With a "Peanut Ball" After Total Knee Replacement. A Randomized Study Evaluating Postoperative Pain and Knee Function.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this randomized controlled study is to evaluate the effect of postoperative exercise with a "peanut ball" after total knee replacement, on pain, intake of pain killers, knee function, and health-related quality of life.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will be included in the study.
At baseline, before surgery, all patients will meet a nurse, a physical therapist, and an orthopedic doctor and answer questions about their health condition and do functional tests.
Each week is randomized to be either "peanut ball" or standard exercise week, with all patients during that week receiving the same treatment. Thus, depending on what week the patients are operated they will be mobilized with postoperative exercise with a "peanut ball" or to a standard exercise program (no peanut ball) 3-5 times/day for 6 weeks. All patients randomized to exercise with a "peanut ball" will receive a ball for free to bring home.
At the ward, the nurses will ask about the patient's pain level two times a day and register all medicines. The physical therapist will introduce the exercise and inform the patients to do the exercise 3-5 times/day a´ 15 minutes and fill in all exercises in an exercise diary.
2 weeks after surgery all patients have a standard visit to a nurse and a physical therapist at the orthopedic department. At this visit, the nurse will register the pain level and all intake of medicine and the physical therapist will measure the range of movement and the sit to stand test.
3 months after surgery all patients have a standard visit to a physical therapist at the orthopedic department. At this visit, all outcomes will be filled in or measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise with a "peanut ball".
Arm Type
Experimental
Arm Description
The rehabilitation program consists of mobility- and functional training exercises with a "peanut ball".
Arm Title
Exercise without "peanut ball"
Arm Type
Active Comparator
Arm Description
The rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball".
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Post-surgical exercise
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) (0-100)
Description
The scale is from 0-100 and a higher value is associated with more pain. 0:no pain and 100: most possible pain.
Time Frame
Change from baseline (before surgery) to 3 months after surgery
Secondary Outcome Measure Information:
Title
Range of movement
Description
The range of movement in the knee is measured with a goniometer. The range of movement may be between 0 degree to 145 degree. A higher degree is better.
Time Frame
Change from baseline (before surgery) to 3 months after surgery
Title
Forgotten Joint Score (FJS)
Description
Is a questionnaire of the patients awareness of their knee. Minimum score:0 (worse outcome), maximum score 100 (best outcome)
Time Frame
Change from baseline (before surgery) to 3 months after surgery.
Title
Knee injury and Osteoarthritis Outcome Score (KOOS-12)
Description
Is a questionnaire of knee related function an quality of life. It consists of three parts: pain (4 items), function (4 items) and knee-specific quality of life (4 items). KOOS-12; in pain sub-item; In the sub-item of walking on a flat ground, going up and down stairs, sitting-reaching, function and daily life; There are patient-specific questions in the sub-item of quality of life, sitting up, standing, getting in and out of the car, turning the affected knee. The total scores obtained from the items in the KOOS-12 scale are calculated and the average of the total score is taken from the three sub-dimensions. If any of the three sub-item scores are missing, the average score cannot be calculated.
Time Frame
Change from baseline (before surgery) to 3 months after surgery.
Title
30 second sit to stand test
Description
A test to evaluate leg strength and endurance. The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).
Time Frame
Change from baseline (before surgery) to 3 months after surgery.
Title
Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)
Description
Is a generic questionnaire about health related quality of life, 0-100, 0: The worst health you can imagine", 100: "the best health you can imagine". Patients are asked to indicate how your health is today and to write the number in an adoining box.
Time Frame
Change from baseline (before surgery) to 3 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.
Exclusion Criteria:
Patients who do not understand and talk the Swedish language
Patients with dementia
Revision surgery of the knee
Unicompartmentmental knee replacement
Facility Information:
Facility Name
Region Skane, VO ortopedi
City
Lund
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.
We'll reach out to this number within 24 hrs