How Muscle and Tendon Properties Contribute to Functional Change Prior to and Following Knee Replacement

NCT04740073 | Suspended

• 1 other identifier: H18-02179
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. This study will use ultrasound and neurophysiological measures to evaluate progressive alterations of tissue to understand functional decline in men and women prior to and following knee replacement surgery. A group of healthy controls not undergoing knee replacement will also be studied to contrast changes in the patient group to normal changes over time. It is hypothesized that from the point of referral to surgery, patients will exhibit reductions in muscle and tendon size (atrophy) and reflex excitability that will be greater in the surgical compared with non-surgical leg, and these changes will precede observable losses in functional measures and strength. Secondly, it is hypothesized that following total knee replacement, muscle and tendon size, reflex activity, strength and functional measures will increase to a level below the pre-surgery values.

Conditions

Total Knee Arthroplasty

Keywords

Knee replacement; function; ultrasound; muscle; tendon; tendon mechanics

Outcome Measures

Primary Outcomes (1)

• Change in knee extension strength

  Maximal isometric knee extensions measured using a dynamometer by having participants push their shin against the dynamometer as hard as they can.

  Through study completion, an average of 1.5 years

Secondary Outcomes (4)

• Change in force steadiness

  Through study completion, an average of 1.5 years

• Change in Young's modulus

  Through study completion, an average of 1.5 years

• Change in timed up and go task

  Through study completion, an average of 1.5 years

• Change in balance

  Through study completion, an average of 1.5 years

Other Outcomes (14)

• Change in hand grip strength

  Through study completion, an average of 1.5 years

• Change in knee range of motion

  Through study completion, an average of 1.5 years

• Change in 30-second chair rise

  Through study completion, an average of 1.5 years

Study Arms (2)

Patients

Persons undergoing total knee arthroplasty

Controls

Persons not undergoing total knee arthroplasty who are age and sex-matched to the patient group.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of 30 patients undergoing unilateral total knee arthroplasty and 30 age- and sex-matched controls not undergoing total knee arthroplasty.

You may qualify if:

• Referred by an orthopedic surgeon to undergo unilateral total knee arthroplasty,
• Age- and sex-matched controls who are not diagnosed with knee or hip osteoarthritis
• Read, speak and understand English

You may not qualify if:

• Prior replacement of a knee or hip joint
• Cardiometabolic or neurological disease beyond typical age-related decline
• Have had quadriceps tendon surgery
• Have had major and recent injury or surgery to either leg in prior 6 months

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Study Officials

• Jennifer Jakobi, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: February 5, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

CA (1)