Patient Recovery After Knee Replacement Surgery

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03518866
• Other study ID #: 14-MK-002
• Status: Active, not recruiting
• Start date: July 21, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Milton Keynes University Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Locations

Country	Name	City	State
United Kingdom	Milton Keynes University Hospital NHS Foundation Trust	Milton Keynes	Bucks

Sponsors (2)

Lead Sponsor	Collaborator
Bev Hoddell	Open University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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