Determinants of Early Functional Outcome After Reconstructive Surgery

Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery

This exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis

Detailed Description

Despite the positive outcomes of total knee arthroplasty (TKA) surgery on symptoms such as pain, perceived function and health-related quality of life (QoL) current research highlights the persistent deleterious effects of retained aberrant neuromuscular alterations on physical function, which may also directly impact falls risk. Importantly, observed increases in neuromuscular deficits that occur prior to surgery track through into the post-operative stage with functional limitations that are sustained and which can persist at least one year after surgery. Clearly, it is crucial to strive to identify modifiable factors that might successfully ameliorate this pathophysiological process prior to surgery, reduce post surgical impairments and which also accelerate recovery.

Among other determinants that might contribute towards understanding of optimal functional recovery following reconstructive knee surgery is the influence of genes. The evaluation of specific genotypes and subsequent protein expression might provide further insight into the extent of genetic influence. For example, it is not yet known whether patients with specific genotypes experience an accelerated recovery. Currently, there is a paucity of research on the influence of gene-environment interactions on an individual's response to physical conditioning.

The proposed research will be an exploratory study, involving four repeated-measures assessments from 10 weeks prior to surgery to 12 weeks after surgery. This study offers a novel evaluation of the overall patterning of changes and will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological performance capabilities, genotypes and levels of habitual physical activity.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • Robert Jones & Agnes Hunt Orthopaedic 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

Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary total knee arthroplasty (TKA).

Description

Inclusion Criteria:

• Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.

Exclusion Criteria:

• Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis
• Rheumatic disorder
• Other orthopaedic conditions affecting lower body function
• Neurological disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Score (KOOS)	Self reported questionnaire which evaluates pain, other symptoms, function in activity of daily living, function in sport and recreation (Sport/Rec), and knee related QoL.	from 10 weeks prior to surgery to 12 weeks after surgery
Oxford knee score (OKS)	Self reported questionnaire which evaluates pain and function.	from 10 weeks prior to surgery to 12 weeks after surgery
Postural stability as assesed by force plate	Postural stability will be assessed using a stable force plate.	from 10 weeks prior to surgery to 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular performance capability	Dynamometer and electromyography measurements will be used to evaluate neuromuscular performance capability.	from 10 weeks prior to surgery to 12 weeks after surgery
Sensorimotor performance capability	Dynamometer and electromyography measurements will be used to evaluate sensorimotor performance capability.	from 10 weeks prior to surgery to 12 weeks after surgery
International Physical Activity Questionnaire (IPAQ).	Self-reported physical activity will be monitored using IPAQ.	from 10 weeks prior to surgery to 12 weeks after surgery
Knee circumference		from 10 weeks prior to surgery to 12 weeks after surgery
DNA genotypes and subsequent protein expression		on the day of surgery and 12 weeks following operation
Psychophysiological response	Self reported. Psychophysiological response will be assessed using Category-Ratio Scale (CR-10); performance profile; short form (SF)-36.	from 10 weeks prior to surgery to 12 weeks after surgery

Collaborators and Investigators

• Sponsor: Queen Margaret University
• Investigators: Principal Investigator: Maria A Peer, Queen Margaret University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 28, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Osteoarthritis; Arthroplasty; Replacement; Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 14/NE/1216