A Myth Orthopaedic Implant Pain in Cold Weather

Ankara Etlik City Hospital

Status: Active, not recruiting

Conditions: Cold Temperature; Pain

Study type: Observational

Funder types: Other

Identifiers

NCT06909760

Implant Pain in Cold

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

210 participants in 1 patient group

patients with orthopaedic implants

Description:

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.