Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)

Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.

Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis; Knee Injury

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Sweden
  • Helsingborg, Sweden, S-251 85
    • Department of Orthopedics, Helsingborg hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will recruit approximately 150 patients annually over 3-4 years with the goal of including at least:

• 200 knees with isolated or combined ACL injuries
• 50 isolated meniscus tears
• 50 primary patellar dislocations
• 50 contusions without ligamentous, cartilage or meniscus injury.

Patients will be recruited using two different strategies:

1. Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital
2. Those referred to the orthopedic outpatient health care unit of Helsingborg hospital due to an acute knee injury by their primary health care unit will be scheduled for a clinical visit for baseline assessment (visit 1) within four weeks from their injury. To facilitate recruitment, primary care units in the local area of Helsingborg will be offered an opportunity to refer all patients with rotational knee trauma and effusion directly to the orthopedic outpatient care unit.

Description

Inclusion Criteria:

1. Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
2. A history of knee injury not more than 4 weeks prior to inclusion
3. Agreement and informed consent to participate in the study

Exclusion Criteria:

1. Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
2. Pregnancy
3. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
4. General disease that effects physical function or systemic medication/abuse of steroids
5. Any other condition or treatment interfering with the completion or assessment of the trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)	5 yrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic osteoarthritis	5 yrs

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: The Swedish Research Council; Crafoord Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee injury; Patellar dislocation; Anterior Cruciate Ligament injury
• Additional Relevant MeSH Terms: Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Wounds and Injuries; Knee Injuries
• Other Study ID Numbers: MOHAK-11