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NCT Number: NCT06909760

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmet Acar

Ankara, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pain on the extremity which was operated

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

    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.

Secondary outcomes

  1. range of motion of the affected joints

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

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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