Patient Recovery After Knee Replacement Surgery

NCT03518866 | Unknown

• 1 other identifier: 14-MK-002
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \* 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bev Hoddell: lead
• Open University: collaborator

Study Sites (1)

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, Bucks, MK6 5LD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33496677 DERIVED

Study Officials

• Blaine Price

  Open University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academic Research Coordinator

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: May 8, 2018
• Study Start: July 21, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Open access as patient data anonymised.

Locations

GB (1)