Exercise Loading Biology Post-Traumatic OsteoArthritis Study - a Pilot and Feasibility Study

NCT06892899 | Enrolling By Invitation

• 1 other identifier: REK sør-øst C #644970
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

FROM RISK FACTORS TO THE PREVENTION OF LONG-TERM CONSEQUENCES AFTER CRUCIATE LIGAMENT INJURY (ACL injury) - This is a research project where we seek new knowledge about why some people have a high risk and others a low risk of developing long-term consequences such as persistent pain, thigh muscle dysfunctions and osteoarthritis after ACL surgery. Through more knowledge about risk factors for persistent pain, thigh muscle dysfunctions, and, in the long term, osteoarthritis, we have a greater opportunity to tailor preventive treatment measures to the individual. We know that a subgroup of those who have undergone ACL surgery does not regain the normal function of the quadriceps muscle, that it does not become as strong as it used to or not quite the same as on the other healthy side. Some may notice this very well, others may not notice as much in the short term. We know that quadriceps dysfunctions can affect the biomechanical joint loading in your knee and can be a contributing risk factor to developing long-term consequences such as persistent pain, thigh muscle function and osteoarthritis after ACL injury. We have methods to measure joint loading conditions in the knee and to identify changes in the cartilage, in the underlying bone tissue of the knee joint, and to measure various aspects of quadriceps muscle strength and dysfunctions. In this study, we want to develop new knowledge about whether there is a difference in knee joint loading conditions and quadriceps muscle function between those who have low risk and those with a higher risk of developing post-traumatic osteoarthritis and whether there is an association between joint loading conditions in the knee after ACL surgery and quadriceps muscle function and symptoms.

Conditions

Anterior Cruciate Ligament Injury; Quadriceps Dysfunction; Knee Joint Loading; Anterior Cruciate Ligament Reconstruction; Risk Factors

Keywords

knee injury; anterior cruciate ligament injury; knee joint loading; quadriceps muscle strength; quadriceps muscle function; post-traumatic knee osteoarthritis; risk factors; prevention

Outcome Measures

Primary Outcomes (1)

• Tibiofemoral contact forces

  Medial and lateral contact forces as a function of time during the standing phase of gait and the loading phase of running and hopping: * Walking and running over floor-embedded force plates (AMTI, Watertown, Massachusetts, USA) * Vertical and horizontal single-leg countermovement jumps with take-off and landing on a force platform. MSK modelling and Statistical Parametric Mapping (SPM) analysis will be used to provide a comprehensive understanding of the loading characteristics throughout the stance phase of gait and during the landing phases of each movement

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

Secondary Outcomes (4)

• Patellofemoral contact forces

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

• Quadriceps and hamstring isokinetic muscle strength tests

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

• Leg press strength/power test

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

• Voluntary quadriceps muscle activation test

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

Other Outcomes (6)

• Questionnaires including PROMs

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

• Magnetic Resonance Imaging (MRI) - bilateral

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

• Ultrasound (US) imaging of quadriceps

  The participant are tested once, as this is a cross-sectional study, 9 months to 2 years after ACLR

Study Arms (1)

Group 1: isolated injury

Group 2: combined injuries (concomitant injuries)

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited through the Norwegian Knee Ligament Registry (NKLR). Established in 2004, its current data show that between 1800 and 2000 individuals go through ACL reconstruction annually in Norway. The NKLR includes nationwide data in Norway with \>90% coverage for surgical data.

You may qualify if:

• Unilateral ACL injury and ACLR (≤ one year between injury and surgery)
• Surgery performed using the BPTB or hamstring grafts
• Age between 16 and 40 years
• Isolated ACL or with concomitant meniscal injury/cartilage injuries at surgery
• Location (living) in the Oslo or Viken areas (due to the need for testing performed at the Norwegian School of Sport Sciences and Oslo University Hospital)
• Healthy, uninjured contralateral knee

You may not qualify if:

• Above 40 years and below 16 years of age
• Previous ACL injury (re-rupture of graft or an ACL injury more than one year between injury and surgery)
• MCL/LCL grade 3 injuries
• Participants with bilateral ACL injuries

Sponsors & Collaborators

• May Arna Risberg: lead
• Helse-Bergen HF: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Department of Sport Medicine, Norwegian School Sport Sciences

Oslo, Oslo County, 0806, Norway

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: March 25, 2025
• Study Start: September 19, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2024-09

Locations

NO (1)