Variations in Osteoarthritic Knee Laxity Between Individuals & Populations

Status Recruiting

Clinical Trial Summary

Severe osteoarthritis of the knee is a condition associated with severe pain, disability and a loss of independence. The most definitive method of surgical treatment for this condition is total knee arthroplasty (TKA). Total knee arthroplasty aims to provide new metallic bearing surfaces within the knee, in order to alleviate the major source of pain. Although total knee arthroplasty is an established surgical treatment option, up to 20% of patients may be dissatisfied with the outcome , and many prostheses fail over time, requiring costly revision surgery. Current understanding suggests that soft tissue balancing has a crucial role to play in the outcome of total knee arthroplasty. Instability after total knee replacement is an important cause of failure. It is not clear what the normal collateral ligament laxity should be. There is a paucity of current data on normal knee collateral ligament laxity . Nevertheless, restoring this may improve patient satisfaction with TKA and longevity. It appears that there is considerable variation between individuals, genders , and ethnic groups , when it comes to "normal" laxity. However, much of the existing data relates to healthy young volunteers , and it is not clear how this information should map against the elderly osteoarthritic population who are most likely to be in need of TKA. Recent advances in computer assisted navigation have provided surgeons with a more precise measure of knee alignment , and knee laxity . Orthopaedic surgeons at New Cross Hospital have been utilising this technology to improve intraoperative placement of total knee replacement implants since 2015. Computer navigation is carried out using the Stryker Precision Navigation System. This system records kinematic and static measurements of knee alignment and laxity in patients just prior to the commencement of the total knee replacement procedure. By gathering and analysing data from this machine, on the degree of laxity in osteoarthritic patients about to undergo TKA, I this study aims to gain a greater understanding of what can be considered "normal" and whether there are significant differences between individuals, and between ethnic populations in this regard. This will help future surgical decision making about how tight or loose prosthetic knee replacements should be, based on individual characteristics.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05018507
Study type	Observational
Source	The Royal Wolverhampton Hospitals NHS Trust
Contact	George Hirsch
Phone	01902 307999
Email	g.hirsch@nhs.net
Status	Recruiting
Phase
Start date	July 2, 2021
Completion date	June 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Variations in Osteoarthritic Knee Laxity Between Individuals and Populations — NavOne

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms