Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)

NCT01382173 | Terminated

• 1 other identifier: MOHAK-11
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Injury; Knee Osteoarthritis

Keywords

Knee injury; Osteoarthritis; Anterior Cruciate Ligament injury; Patellar dislocation

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  5 yrs

Secondary Outcomes (1)

• Radiographic osteoarthritis

  5 yrs

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Agreement and informed consent to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead
• The Swedish Research Council: collaborator
• Crafoord Foundation: collaborator

Study Sites (1)

Department of Orthopedics, Helsingborg hospital

Helsingborg, S-251 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Joint fluid, Serum \& Plasma

MeSH Terms

Conditions

Knee Injuries; Osteoarthritis, Knee; Osteoarthritis; Anterior Cruciate Ligament Injuries; Patellar Dislocation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Joint Dislocations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: September 1, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

SE (1)