Patient Recovery After Knee Replacement Surgery

• Conditions: Total Knee Replacement

• Registration Number: NCT03518866
• Lead Sponsor: Bev Hoddell

Brief Summary

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

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 Timeline

• Study Start: 2015-07-21
• Study First Submitted: 2017-09-11
• Primary Completion: 2017-12-31
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-05-08
• Last Update Posted: 2018-05-08
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The OKS (Oxford Knee Score) at 12 months post surgery	12 months	Routine physiotherapy review appointment 12 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The Pain score at 6 months post surgery	6 months	Routine physiotherapy review appointment 6 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
Mean weekly Oxford Knee Score for 6 weeks following surgery.	6 weeks	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.
Mean Daily Pain Score over 6 weeks following surgery	6 weeks	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.
Change in mean weekly step count between pre surgery and 6 weeks post surgery.	7 weeks	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.
The OKS (Oxford Knee Score) at 6 months post surgery	6 months	Routine physiotherapy review appointment 6 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The Pain score at 12 months post surgery	12 months	Routine physiotherapy review appointment 12 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.

Trial Locations

Locations (1)

Milton Keynes University Hospital NHS Foundation Trust; 🇬🇧 Milton Keynes, Bucks, United Kingdom