A Myth Orthopaedic Implant Pain in Cold Weather

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Cold Temperature

Detailed Description

Fractures and degenerative joint diseases are common medical problems that many people experience throughout their lives. Orthopaedic implants are widely manufactured and used worldwide to replace a degenerated joint or to reduce a fractured bone and promote healing (1). In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material (2). Today, this rate is thought to increase much more due to increasing population, developing and increasing number of motorised vehicles and increasing surgical indications. Although the removal of these implants is a very controversial issue in the literature, most surgeons do not recommend routine removal of implants unless there are complications (3). In a study, it was reported that the reasons for implant removal were osteomyelitis and persistent pain in only 28% of patients, but the reason for removal was 'patient request' in 72% of patients who had implants removed (4).

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 was examined, there was 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.

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06170
    • Ahmet Acar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All population

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion of the affected joints	Range of motion of the affected extremities will be evaluated with goniometer. Affected joints mean the joints which is proximal and distal to orthopedic implant used. If there is an implant in tibia. Range of motion of the knee and ankle joints will be measured.	Patients are called for follow up twice a year with 6 months interval

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Estimated): May 25, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: pain; implant; cold weather
• Other Study ID Numbers: Implant Pain in Cold

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No