Biomechanical Osteoarthritis Outcomes in Meniscectomy Patients

NCT03350204 | Completed

• 1 other identifier: HSR1617-56
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The key aim of this study is to examine biomechanical measures associated with osteoarthritis (OA) progression in patients who have lateral and medial menisci injuries during various tasks. The likelihood is that individuals who have a meniscal injury often develop knee osteoarthritis. Therefore understanding biomechanical changes from the injury, specifically undertaking both functional and sporting activities, may provide a conservative approach to delaying or minimising the development of OA. Three-dimensional kinetic and kinematic measures will be assessed during seven tasks (walking, running, side cuts, single leg landing, small knee bend squat and isokinetic leg strength), prior to and following treatment. In addition, Strength and balance will be assessed to indicate if there is more work in the rehabilitation program that is needed for functional movement.

Conditions

Meniscus Injury; Meniscectomy; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Biomechanics

  All sections of the knee adduction moment curve (different peaks) and also the knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions. Magnitudes and durations of three muscle co-contractions will be calculated from the surface EMG data

  Immediate

Secondary Outcomes (3)

• Knee injury and osteoarthritis outcome score (KOOS)

  Immediate

• Patient-perceived global change in pain

  Immediate

• Tampa Scale of Kinesiophobia (TSK)

  Immediate

Study Arms (2)

Meniscus Injured

EXPERIMENTAL

These participants will come in pre and post operation

Procedure: Meniscectomy

Healthy

EXPERIMENTAL

These participants will be used as a standardised comparison for the patient group

Other: Helathy control comparison

Interventions

Meniscectomy PROCEDURE

This will be to see what occurs in both kinetics and kinematics after you have a surgery and how this links on to osteoarthritis

Meniscus Injured

Helathy control comparison OTHER

This group will be used to get a baseline for normal and natural walking, running and other several tasks which will be used as a comparison for the meniscus injury group.

Healthy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 40 years
• Meniscal injury sustained during a sporting task e.g. a sports cutting manoeuvre (Football, Basketball, Netball, Hockey etc.)
• 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
• Medial or a lateral meniscal tear and listed for surgery
• Surgery in the last 12 months for meniscal injury (Meniscectomy or Meniscal Repair)

You may not qualify if:

• History of lower extremity surgeries e.g. ACL reconstruction (other than meniscal injury)
• 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
• Degenerative aspects including tear

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

Manchester Institute of Health and Performance

Manchester, Lancashire, M11 2AZ, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Meniscectomy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Model Details: Testing both meniscus patients and uninjured individuals for comparison

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: November 1, 2017
• 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)