Clinical trial NCT06909760: A Myth Orthopaedic Implant Pain in Cold Weather
Official title: A Myth Orthopaedic Implant Pain in Cold Weather
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain
Cold Temperature
Keywords: pain
implant
cold weather
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All population

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain on the extremity which was operated
timeFrame: Patients are called for follow up twice a year with 6 months interval
Secondary outcomes:
measure: range of motion of the affected joints
timeFrame: Patients are called for follow up twice a year with 6 months interval
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ahmet Acar
Study officials:
References: