Variations in Osteoarthritic Knee Laxity Between Individuals and Populations

NCT05018507 | Completed

• 1 other identifier: 2021ORT117
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthritis

Outcome Measures

Primary Outcomes (3)

• The degree of ligamentous laxity in severely arthritic knees

  kinematic and static measurements pre and post op laxity in flexion and extension

  4 weeks

• Pattern of laxity in relation to pre-existing knee deformity

  Establish a pattern of laxity in relation to pre-existing knee deformity

  4 weeks

• Baseline ligamentous laxity between males and females, and between Caucasian and Asian populations

  To compare baseline ligamentous laxity between males and females, and between Caucasian and Asian populations

  4 weeks

Study Arms (1)

total knee arthroplasty patients

data collection only

Other: Data collection only

Interventions

Data collection only OTHER

No intervention, just data collection from system machines

total knee arthroplasty patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing total knee arthroplasty between 2015 and 2019 under the care of a single Consultant

You may qualify if:

• All cases of TKA recorded on the 2 Stryker navigation machines based at New Cross and Cannock Chase Hospitals will be included in the study. Duplicates will be identified and removed from the case series.

You may not qualify if:

• Cases in which there is incomplete or inadequate kinematic data recorded in the machine database will be excluded from the study.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Study Officials

• George Hirsch

  The Royal Wolverhampton NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: August 24, 2021
• Study Start: July 2, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)