A Myth Orthopaedic Implant Pain in Cold Weather

NCT06909760 | Active Not Recruiting

• 1 other identifier: Implant Pain in Cold
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature is examined, there is only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

Conditions

Pain; Cold Temperature

Keywords

pain; implant; cold weather

Outcome Measures

Primary Outcomes (1)

• Pain on the extremity which was operated

  Pain will be assessed with "Visual Analogue Scale". Patients will be asked if they have pain on their extremity with orthopedic implant both in cold and hot weather conditions.

  Patients are called for follow up twice a year with 6 months interval

Secondary Outcomes (1)

• range of motion of the affected joints

  Patients are called for follow up twice a year with 6 months interval

Study Arms (1)

patients with orthopaedic implants

The contact information of the patients who volunteered to participate in the study will be obtained and the patients will be called for 2 separate controls based on the one-week average value of the air temperature (2 periods with a one-week average air temperature between 27-35°C (hot weather) and 0-8°C (cold weather)). Parameters to be investigated in patients called for control in both weather conditions; * Whether there are any complaints at the implant site * Visual pain score (VAS) * Proximal and distal range of motion (ROM) of the operated extremity * Chills/shivering according to the opposite extremity * Pain catastrophizing scale (PCS) * Measures taken in cold weather * The temperature difference between the implant site and the same site in the opposite extremity will be measured using thermal thermometers.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All population

You may qualify if:

• patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.

You may not qualify if:

• Patients \<18 years of age
• Patients with incomplete fracture union
• Patients with joint prosthesis (knee, hip, shoulder prosthesis, etc.)
• Patients with complications in the operated extremity (implant infection, implant failure, etc.)
• Acute or chronic infection (bacterial or viral infection) of any body site
• Patients diagnosed with neuropathy (diabetic, alcoholism, autoimmune, nutritional deficiency, infectious)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ahmet Acar

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor İnvestigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 3, 2025
• Study Start: July 31, 2024
• Primary Completion: March 10, 2025
• Study Completion: May 25, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-03

Locations

TU (1)