Balance After Knee Arthroplasty

• Sponsor: Johannes Kepler University of Linz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04681404
• Collaborator: Kepler University Hospital (Other)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 34.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.

Condition or Disease	Intervention/Treatment	Phase
Postural Balance; Knee Arthroplasty; Quality of Life	Procedure: Knee Arthroplasty	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
• Actual Study Start Date: Jan 11, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Total Knee Arthroplasty (TKA) Patients intended to undergo surgery for total knee arthroplasty	Procedure: Knee Arthroplasty; Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
Active Comparator: Unicompartmental Knee Arthroplasty (UKA) Patients intended to undergo surgery for unicompartmental knee arthroplasty	Procedure: Knee Arthroplasty; Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
No Intervention: Healthy Control

Outcome Measures

Primary Outcome Measures

1. Center of pressure track (COPT) [Before surgery]

   Posturographic Parameter

2. Center of pressure track (COPT) [Day 3-7 after surgery]

   Posturographic Parameter

3. Center of pressure track (COPT) [3 months after surgery]

   Posturographic Parameter

4. Center of pressure track (COPT) [1 year after surgery]

   Posturographic Parameter

Secondary Outcome Measures

1. Functional reach test [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

2. Timed up and go - test [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

3. Knee Injury and Osteoarthritis Outcome Score [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

   Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

4. EQ-5D - Score [Before surgery; 1 year after surgery]

   Scale: Points, Minimum: 1, Maximum: <0, higher score means better outcome

5. 10 m Walking test [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

6. WOMAC Score [Before surgery; 1 year after surgery, higher score means better outcome]

   Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome

7. Forgotten Joint Score [Before surgery; 1 year after surgery]

   Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

8. Oxford Knee Score [Before surgery; 1 year after surgery]

   Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome

9. Knee Society Score [Before surgery; 1 year after surgery]

   Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

10. The University of California at Los Angeles Activity Score [Before surgery; 1 year after surgery]

    Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome

11. Area of Sway [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

12. Frequency of Sway [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

13. Harmony Index [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

14. Stability energy [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

15. Movement control [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

16. Feedback (visual, somatosensoric, vestibular) [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

17. Weight Distribution Index [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

18. Fulfillment of Tests [Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery]

    Posturographic Parameter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary gonarthrosis

• planned TKA or UKA

• adequate cognitive and lingual competence

• informed consent

Exclusion Criteria:

• TKA or UKA revision

• Surgery after trauma

• Rheumatic disease

• Neurologic disease

• previous arthroplasty of the lower extremity (<9 months)

• cardiovascular disease

• restricted weight bearing of the lower extremity after surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kepler University Hospital	Linz		Austria	4020

Sponsors and Collaborators

• Johannes Kepler University of Linz
• Kepler University Hospital

Investigators

• Principal Investigator: Christian Mittermaier, Dr, Kepler University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian Mittermaier, Christian Mittermaier, MD, Johannes Kepler University of Linz
• ClinicalTrials.gov Identifier: NCT04681404
• Other Study ID Numbers: PMR_Knee TKA 001
• First Posted: Dec 23, 2020
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 28, 2022