A Myth Orthopaedic Implant Pain in Cold Weather

N/AActive Not RecruitingNCT06909760

Ankara Etlik City Hospital210 enrolled

Overview

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.

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

210

Conditions

Pain Cold Temperature

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Ahmet Acar

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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