The Effect of Commercially Available Footwear Interventions in Meniscectomy Patients

NCT03379415 | Completed

• 1 other identifier: HSR1617-140
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Injuries to the meniscus are common in sport. A meniscectomy is often performed to manage symptoms associated with the meniscal injury. Following a meniscectomy individuals are highly likely to develop knee osteoarthritis (OA). Footwear interventions have demonstrated biomechanical changes during walking and running, in healthy and individuals with osteoarthritis. With the increased risk of developing OA associated with meniscectomy patients, understanding biomechanical changes with footwear when compared to healthy individuals, may provide a conservative approach to delaying or minimising the development of (OA). There is no current literature assessing the effect footwear has post meniscectomy, so this is a very novel approach and can yield important results for the management of future risks. Current evidence supports the use of footwear interventions aiming to minimise OA progression in older adults during walking. Yet, meniscectomy patients who have sustained an injury during sport are likely to continue to participate in sport following treatment in their usual footwear. Further evidence is required to better understand the effect of footwear interventions during dynamic movements often performed in sport. Previous studies have assessed customised footwear interventions, however these interventions are not representative of commercially available interventions that could be widely used by the general population. Therefore assessing commercially available footwear will give a more realistic approach to conservative treatment for meniscectomy patients. This project aims to examine biomechanical differences between commercially available footwear conditions in healthy individuals and individuals who have had a meniscal injury. Three-dimensional kinetic and kinematic measures will be assessed during five tasks (walking, running, 90 degrees side cut, single leg landing, and small knee bend squat), for different footwear conditions.

Conditions

Meniscus Injury; Osteoarthritis, Knee; Footwear

Keywords

Meniscectomy; Footwear; Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Biomechanical analysis using 3D motion capture looking at kinematics and kinetics

  Knee adduction moment curve (different peaks) will be assessed for differences between conditions.

  Change from Baseline until 1 year

• Electromyography analysis of muscle co-contraction

  The co-activation of quadriceps and hamstrings will be analysed using EMG. EMG will first be normalized using MVC and then the co-contraction will be analysed.

  Change from Baseline until 1 year

• Biomechanical analysis using 3D motion capture looking at kinematics and kinetics

  Knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions.

  Change from Baseline until 1 year

Secondary Outcomes (4)

• Knee injury and osteoarthritis outcome score (KOOS)

  Change from Baseline until 1 year

• Patient-perceived global change in pain

  Change from Baseline until 1 year

• Tampa Scale of Kinesiophobia (TSK)

  Change from Baseline until 1 year

• Comfort Rating Questionnaire

  Change from Baseline until 1 year

Study Arms (2)

Meniscus Injured

EXPERIMENTAL

These meniscus patients will be recruited to participate in a single session to wear 4 different pairs of shoes

Device: Footwear

Footwear

EXPERIMENTAL

4 Different types of trainers will be used to see the difference in gait in meniscectomy patients

Procedure: Gait analysis

Interventions

Footwear DEVICE

Different types of footwear will be tested to see if these can be used to help slow the progression of osteoarthritis in meniscectomy patients or even stop it from occurring.

Meniscus Injured

Gait analysis PROCEDURE

Gait analysis will be done during several different tasks wear the footwear

Footwear

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 40 years
• Compete and or play sport a minimum two times a week
• Able to perform sport specific tasks including running, single leg landing and small knee bend squat
• Meniscectomy group - has had a meniscectomy surgery following a traumatic meniscal injury during a sporting task.

You may not qualify if:

• History of lower extremity surgeries (other than a meniscectomy) e.g. ACL reconstruction
• Evidence of knee osteoarthritis development either assessed clinically (based on ACR criteria) or radiographically (Kellgren-Lawrence grade \>1)
• Previous history of traumatic (other than the sustained meniscal injury), inflammatory or infectious pathology in the lower extremity
• Evidence of ligament laxity

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

Manchester Institute of Health and Performance

Manchester, Lancashire, M11 2AZ, United Kingdom

Location

Related Publications (1)

• Starbuck C, Walters V, Herrington L, Barkatali B, Jones R. Knee Offloading by Patients During Walking and Running After Meniscectomy. Orthop J Sports Med. 2024 Mar 21;12(3):23259671231214766. doi: 10.1177/23259671231214766. eCollection 2024 Mar.

  PMID: 38524891 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participant is blinded to the randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Testing meniscus patients for several different shoes

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 20, 2017
• Study Start: February 1, 2018
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)