Clinical trial NCT05137834: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analogue scale (VAS) (0-100)
timeFrame: Change from baseline (before surgery) to 3 months after surgery
Secondary outcomes:
measure: Range of movement
timeFrame: Change from baseline (before surgery) to 3 months after surgery
measure: Forgotten Joint Score (FJS)
timeFrame: Change from baseline (before surgery) to 3 months after surgery.
measure: Knee injury and Osteoarthritis Outcome Score (KOOS-12)
timeFrame: Change from baseline (before surgery) to 3 months after surgery.
measure: 30 second sit to stand test
timeFrame: Change from baseline (before surgery) to 3 months after surgery.
measure: Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)
timeFrame: Change from baseline (before surgery) to 3 months after surgery.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region Skane, VO ortopedi
Study officials:
References: