Protective Role of Muscle Function for Early Features of Knee Osteoarthritis After Anterior Cruciate Ligament Injury

NCT ID: NCT03473873

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-09
• Study Completion Date: 2023-07-01

Brief Summary

In this longitudinal prospective cohort study including young people with anterior cruciate ligament reconstruction (ACLR), the aims are to 1) study the association between different measures of muscle function and early future of knee osteoarthritis (OA) assessed as patient-reported pain, 2) explore potential associations between muscle function and features indicative of early radiographic OA measured with MRI, and early detection of OA in biomarker profiles, respectively, 3) monitor the patients' functional status, and early OA development over time and 4) investigate the prevalence of early knee OA in individuals 1 and 3 years post ACLR, respectively, compared to non-injured controls.The main hypothesis is that knee extensor weakness predicts future symptomatic OA of the knee (KOOS pain).

Detailed Description

This is a longitudinal, prospective, cohort study. The reporting will adhere to the STROBE guidelines. Approximately 100 patients 12 months (range 10 - 16 months) after anterior cruciate ligament reconstruction (ACLR) will be recruited from Skåne University Hospital, Sweden and Ullevål Hospital, Oslo, Norway. The majority of the patients (approx. 80 %) will be recruited in Sweden. As a sample of convenience, 20 age- and sex-matched non-knee injured individuals will be recruited among students in Lund, Sweden.

A research coordinator at each site will determine eligibility for the study, based on pre-specified inclusion and exclusion criteria. Patients will be provided with written and oral information about the study. Patients who accept to participate will be assessed with various measures of muscle function, patient-reported outcomes, MRI, and blood samples for biomarker analyses, at baseline (1 year after ACLR) and 2 years later (3 years after ACLR).

For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression model will be used to elucidate the influence of change in each muscle function variable on change in primary, secondary and exploratory outcomes (biomarkers), adjusted for baseline values. Separate linear regression models will also be used to elucidate the influence of demographic factors on change in muscle function, self-reported outcomes, and early OA. Assuming a clinically relevant correlation of 0.30 between knee extension strength and self-reported pain, 84 patients are needed with 80% power at the 5% significance level. Based on this calculation, 100 patients will be included, including an approximate drop-out of 15%. For explorative purposes, an analysis of covariance (ANCOVA) will be used to investigate differences in the presence of early knee OA between the 100 patients with ACLR and twenty sex and age matched non-injured individuals, adjusting for activity level.

Conditions

Knee Osteoarthritis; Anterior Cruciate Ligament Injury; Osteoarthritis, Knee; Muscle Weakness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SHIELD

Patients with anterior cruciate ligament injury

Measures of muscle function

Intervention Type: OTHER

The participants will be assessed with various measures of muscle function at baseline and at follow up including: Isokinetic knee muscle strength, Isometric strength of trunk and lower extremity, single-leg hop for distance (SLHD), side hop, postural orientation errors (single leg-squat, stair descending, forward lunge, SLHD), hip and ankle range of motion, and muscular activation patterns.

Interventions

Measures of muscle function

The participants will be assessed with various measures of muscle function at baseline and at follow up including: Isokinetic knee muscle strength, Isometric strength of trunk and lower extremity, single-leg hop for distance (SLHD), side hop, postural orientation errors (single leg-squat, stair descending, forward lunge, SLHD), hip and ankle range of motion, and muscular activation patterns.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• One year after ACL reconstruction (ACLR)
• With or without associated injuries to other structures of the knee (e.g., collateral ligament(s), meniscal injury)
• Age 18-35 years

• Age 18-35 years
• No previous injuriy or surgery to either knee

Exclusion Criteria

• Less than 10 months after ACLR
• More than 16 months after ACLR
• Injury or surgery to other knee (e.g., ACL, meniscal)
• Previous knee surgery index knee
• Previous serious knee injury index knee resulting in pain, swelling, and/or requiring inpatient or outpatient health care (e.g., ACLR, meniscus, patella luxation)
• Diseases or disorders overriding the knee condition (e.g., neurological disease)
• Contraindications for MRI
• Not understanding the languages of interest (any Scandinavian language or English)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Ageberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Health Sciences, Lund University, PO Box 157, 221 00 Lund, Sweden

May Arna Risberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Division of Orthopedic Surgery, PO.Box 4956 Nydalen, 0424 Oslo, Norway

Locations

May Arna Risberg

Oslo, , Norway

Eva Ageberg

Lund, , Sweden

Countries

Norway; Sweden

Other Identifiers

2016/319

Identifier Type: -

Identifier Source: org_study_id