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A Myth Orthopaedic Implant Pain in Cold Weather

A Myth Orthopaedic Implant Pain in Cold Weather

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06909760
Enrollment
210
Registered
2025-04-03
Start date
2024-07-31
Completion date
2025-05-25
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold Temperature, Pain

Keywords

pain, implant, cold weather

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.

Interventions

None listed

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain on the extremity which was operatedPatients are called for follow up twice a year with 6 months intervalPain 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.

Secondary

MeasureTime frameDescription
range of motion of the affected jointsPatients are called for follow up twice a year with 6 months intervalRange 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026