Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures

NCT03769909 | Unknown DMC

• 1 other identifier: S-20170139
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-articular fracture is a very common fracture. The only method to treat these fractures is surgery with plate and screws followed by rehabilitation. Even though the surgeons do their best to restore the anatomy, up to 40 percent of the patients develop osteoarthritis after 10 years. Previous research has shown that immediately after fracture in the joint, the body starts an inflammatory response and activates a series of biomarkers inside the joint space. Some of these biomarkers are believed to break down the cartilage resulting in development of osteoarthritis, despite surgical treatment. Currently it is still unknown, which biomarkers are activated in the joint space, and how we can stop their deleterious action in order to prevent cartilage degradation. The purpose of this project is to identify the biomarkers in the joint space after an intra-articular ankle fracture and to evaluate how these biomarkers affect the short- and mid-terms clinical outcomes. As secondary outcomes we evaluate how fracture classification and fracture reduction affect clinical outcomes and physical activity after surgery.

Conditions

Ankle Fractures; Intra-Articular Fractures; Osteoarthritis

Keywords

PTOA; Osteoarthritis; Intra-Articular Fractures; Ankle Fractures; Cytokines; Biomarkers; Inflammation; Pro-inflammatory; Cartilage; Fracture; Joint Injury

Outcome Measures

Primary Outcomes (2)

• Concentration of cytokines in fracture ankle versus non-fracture ankle

  Multiplex ELISA kits will be use to identify cytokines in both ankles. Cytokines with significant difference will be identified.

  During surgery

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (AOFAS)

  The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of functional foot score (AOFAS), The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points

  12 months after surgery

Secondary Outcomes (8)

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (FFI.DK)

  12 months after surgery

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (EQ5D-5L)

  12 months after surgery

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (VAS-score)

  12 months after surgery

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (Swelling)

  12 months after surgery

• Cytokines (identified in primary outcome 1) correlation with clinical outcomes (FFI.DK)

  3 months after surgery

Other Outcomes (12)

• Correlation between fracture classification and clinical outcomes (AOFAS)

  12 months after surgery

• Correlation between fracture classification and clinical outcomes (FFI.DK)

  12 months after surgery

• Correlation between fracture classification and clinical outcomes (EQ5D-5L)

  12 months after surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalize in Odense University, Svendborg (31th. Oct. 2017-Jan. 2019) will be screened for eligibility.

You may qualify if:

• Age between 18 and 65 years
• Existence of an acute fracture involving the ankle (location AO43,AO44) requiring open or closed reduction and internal or external fixation within 14 days
• Being able to read and understand Danish
• Informed consent

You may not qualify if:

• Open fractures
• Associated arterial and nerve injuries
• Multiple injured patients with an Injury Severity Score \>16
• Primary or secondary infections
• Injuries associated to a Charcot foot
• Signs of existing OA on X-ray
• Others

Sponsors & Collaborators

• University of Southern Denmark: lead
• University of Freiburg: collaborator
• Odense University Hospital: collaborator
• The Danish Rheumatism Association: collaborator
• Hartmann Fonden: collaborator
• AP Møller Fond: collaborator

Study Sites (1)

The Orthopaedic Research Unit

Odense, 5000, Denmark

Location

Related Publications (2)

• Pham TM, Kristiansen EB, Frich LH, Lambertsen KL, Overgaard S, Schmal H. Association of acute inflammatory cytokines, fracture malreduction, and functional outcome 12 months after intra-articular ankle fracture-a prospective cohort study of 46 patients with ankle fractures. J Orthop Surg Res. 2021 May 25;16(1):338. doi: 10.1186/s13018-021-02473-8.

  PMID: 34034772 DERIVED

• Pham TM, Frich LH, Lambertsen KL, Overgaard S, Schmal H. Elevation of Inflammatory Cytokines and Proteins after Intra-Articular Ankle Fracture: A Cross-Sectional Study of 47 Ankle Fracture Patients. Mediators Inflamm. 2021 Jan 8;2021:8897440. doi: 10.1155/2021/8897440. eCollection 2021.

  PMID: 33505222 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (5.0-20.0 ml) Synovial Fluids (1.0-10.0 ml) from both ankle joints

MeSH Terms

Conditions

Ankle Fractures; Intra-Articular Fractures; Osteoarthritis; Inflammation; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Ankle Injuries; Leg Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren Overgaard, Professor

  The Orthopaedic Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: December 10, 2018
• Study Start: October 31, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

DK (1)