Determinants of Early Functional Outcome After Reconstructive Surgery

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381873
• Other study ID #: 14/NE/1216
• Status: Completed
• Phase: N/A
• First received: February 28, 2015
• Last updated: March 6, 2017
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United Kingdom	Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust	Oswestry	Shropshire

Sponsors (1)

Lead Sponsor	Collaborator
Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Oxford knee score (OKS)	Self reported questionnaire which evaluates pain and function.	from 10 weeks prior to surgery to 12 weeks after surgery
Primary	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	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
Secondary	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
Secondary	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
Secondary	Knee circumference		from 10 weeks prior to surgery to 12 weeks after surgery
Secondary	DNA genotypes and subsequent protein expression		on the day of surgery and 12 weeks following operation
Secondary	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