Patient Recovery After Knee Replacement Surgery

A Feasibility Study to Monitor Post Discharge Activity of Patient Recovery After Knee Replacement Surgery

This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.

Study Overview

• Status: Unknown
• Conditions: Total Knee Replacement

Detailed Description

This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.

Primary Aims The primary objective of this study is to compare step count and activity levels with key outcome measures - including pain scores and painkiller usage - to determine whether more active people have better recovery.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United Kingdom
  • Bucks
    • Milton Keynes, Bucks, United Kingdom, MK6 5LD
      • Milton Keynes University Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing elective single total knee replacement surgery at Milton Keynes University Hospital under the care of the principal investigator with no other relevant co-morbidities.

Description

Inclusion Criteria:

* Adult

• Must be able to converse and understand English
• The participants must be selected for for single full knee replacement surgery at Milton Keynes University Hospital
• The participant must have access to a computer at home or be willing to plug a synchronization box into their broadband router
• The participants must have access to a valid email address or be able to create one for the purpose of this study (this may belong to a spouse, partner, friend or relative) or have access to a mobile phone able to receive SMS (text) messages

Exclusion Criteria:

• Insufficient language skills to understand the study procedures
• Cognitive impairment
• Medical conditions (e.g., severe neurological disorder, acute cancer, psychiatric disorder, acute infections) that prevent participation in the study
• Wheelchair user
• Significant lower limb arthritic joints
• Severe mobility limitation due to central or peripheral respiratory dysfunction
• Severe mobility limitation due to central or peripheral nervous system disorders
• Severe mobility limitation due to spinal condition
• Severe mobility limitation due to musculoskeletal disabilities
• Rheumatoid arthritis due to joint pain in both upper and lower limbs
• Amputee
• Dementia

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean weekly step count between pre surgery and 6 weeks post surgery.	Daily activity level of participant as measured by step count automatically on commercial step counter at one minute granularity from up to one week before surgery up to 6 weeks post surgery. Step count data for days which are deemed non compliant (not wearing device long enough) will be ignored. Total average daily step count (for compliant days) each week will be reported. The outcome measure we plan to use will be the mean daily step count from the 6th week post op. The baseline will be the mean step count from the 1 week prior to surgery.	7 weeks
Mean Daily Pain Score over 6 weeks following surgery	Participants will be asked to record their NRS-11 (Numeric Rating Scale) pain level in the morning, afternoon and evening daily in a paper diary for six weeks after surgery. NRS-11 is an integer scale from 0-10 with 0 representing no pain and 10 representing worst pain possible. The outcome measure will be the mean pain score from the 6 week post op period.	6 weeks
Mean weekly Oxford Knee Score for 6 weeks following surgery.	For the 6 weeks following surgery, at the end of each week patients will be asked to fill in the 12 question Oxford Knee Score (OKS) questionnaire which will result in an integer score from 0-48 for each week. The outcome measure will be the mean OKS over the 6 week post op period.	6 weeks
The OKS (Oxford Knee Score) at 6 months post surgery	Routine physiotherapy review appointment 6 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.	6 months
The OKS (Oxford Knee Score) at 12 months post surgery	Routine physiotherapy review appointment 12 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.	12 months
The Pain score at 6 months post surgery	Routine physiotherapy review appointment 6 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.	6 months
The Pain score at 12 months post surgery	Routine physiotherapy review appointment 12 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.	12 months

Collaborators and Investigators

• Sponsor: Bev Hoddell
• Collaborators: Open University
• Investigators: Study Chair: Blaine Price, Open University

Publications and helpful links

General Publications

• Kelly R, Jones S, Price B, Katz D, McCormick C, Pearce O. Measuring Daily Compliance With Physical Activity Tracking in Ambulatory Surgery Patients: Comparative Analysis of Five Compliance Criteria. JMIR Mhealth Uhealth. 2021 Jan 26;9(1):e22846. doi: 10.2196/22846.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14-MK-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymised raw participant data for basic demographics, surgery date, daily step count, pain scores, Oxford Knee scores will be shared on the institutional open data archive.
• IPD Sharing Time Frame: Raw data will be published on the institutional open data archive when the first publication is submitted for review and available for 10 years. Submission is anticipated in mid to late 2018.
• IPD Sharing Access Criteria: Open access as patient data anonymised.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No