Knee OsteoarthritisNCT05137834
The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.
A study testing Exercise in people with Knee Osteoarthritis, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.
Who cannot join
- Patients who do not understand and talk the Swedish language
- Patients with dementia
- Revision surgery of the knee
- Unicompartmentmental knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Postoperative Rehabilitation With a "Peanut Ball" After Total Knee Replacement. A Randomized Study Evaluating Postoperative Pain and Knee Function.
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Post-surgical exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise with a "peanut ball". | Experimental | The rehabilitation program consists of mobility- and functional training exercises with a "peanut ball". Receives: Other: Exercise |
| Exercise without "peanut ball" | Active comparator | The rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball". Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (before surgery) to 3 months after surgery
Secondary outcomes (5)
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.
Measured: Change from baseline (before surgery) to 3 months after surgery
Forgotten Joint Score (FJS)
Is a questionnaire of the patients awareness of their knee. Minimum score:0 (worse outcome), maximum score 100 (best outcome)
Measured: Change from baseline (before surgery) to 3 months after surgery.
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.
Measured: Change from baseline (before surgery) to 3 months after surgery.
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).
Measured: Change from baseline (before surgery) to 3 months after surgery.
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.
Measured: Change from baseline (before surgery) to 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start10 Jan 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137834
- Sponsor's protocol ID
- 2021-02904
- Status last verified
- Jul 2025
- First submitted
- 16 Nov 2021
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Rehabilitation With a "Peanut Ball" After Total Knee Replacement. A Randomized Study Evaluating Postoperative Pain and Knee Function.
- ClinicalTrials.gov ID
- NCT05137834
- Acronym / sponsor ID
- 2021-02904
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with a "peanut ball". | Experimental | Other: ExerciseThe rehabilitation program consists of mobility- and functional training exercises with a "peanut ball". |
| Exercise without "peanut ball" | Active comparator | Other: ExerciseThe rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball". |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.
Key exclusion criteria (4 listed)
- Patients who do not understand and talk the Swedish language
- Patients with dementia
- Revision surgery of the knee
- Unicompartmentmental knee replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePost-surgical exercise | Other | Exercise with a "peanut ball"., Exercise without "peanut ball" |
Primary outcome
Visual analogue scale (VAS) (0-100)
Time frame: Change from baseline (before surgery) to 3 months after surgery
The scale is from 0-100 and a higher value is associated with more pain. 0:no pain and 100: most possible pain.
5 secondary outcomes
Range of movement
Time frame: Change from baseline (before surgery) to 3 months after surgery
Forgotten Joint Score (FJS)
Time frame: Change from baseline (before surgery) to 3 months after surgery.
Knee injury and Osteoarthritis Outcome Score (KOOS-12)
Time frame: Change from baseline (before surgery) to 3 months after surgery.
30 second sit to stand test
Time frame: Change from baseline (before surgery) to 3 months after surgery.
Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)
Time frame: Change from baseline (before surgery) to 3 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Osteoarthritis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (0-100) (time frame: Change from baseline (before surgery) to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.