NCT05137834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

November 16, 2021

Last Update Submit

July 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline (before surgery) to 3 months after surgery

Secondary Outcomes (5)

  • Range of movement

    Change from baseline (before surgery) to 3 months after surgery

  • Forgotten Joint Score (FJS)

    Change from baseline (before surgery) to 3 months after surgery.

  • Knee injury and Osteoarthritis Outcome Score (KOOS-12)

    Change from baseline (before surgery) to 3 months after surgery.

  • 30 second sit to stand test

    Change from baseline (before surgery) to 3 months after surgery.

  • Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)

    Change from baseline (before surgery) to 3 months after surgery.

Study Arms (2)

Exercise with a "peanut ball".

EXPERIMENTAL

The rehabilitation program consists of mobility- and functional training exercises with a "peanut ball".

Other: Exercise

Exercise without "peanut ball"

ACTIVE COMPARATOR

The rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball".

Other: Exercise

Interventions

Post-surgical exercise

Exercise with a "peanut ball".Exercise without "peanut ball"

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.

You may not qualify if:

  • Patients who do not understand and talk the Swedish language
  • Patients with dementia
  • Revision surgery of the knee
  • Unicompartmentmental knee replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skane, VO ortopedi

Lund, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 30, 2021

Study Start

January 10, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations