PainNCT06909760
Orthopaedic Implant Pain in Cold Weather
An observational study of Pain and Cold Temperature, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Cold Temperature, Pain Catastrophizing
- How many people
- 268 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2024to 25 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-90 years with orthopaedic fracture implants.
Who may be able to join
- patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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. In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material. 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. 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.
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.
- Conditions
- Pain, Cold Temperature, Pain Catastrophizing, Cold Exposure
- Keywords
- pain, implant, cold weather, pain catastrophizing scale, orthopaedic implant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with orthopaedic implants | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cold-weather assessment: after full recovery and at least 1 year after surgery, when the official 7-day mean air temperature is 0-8°C. Hot-weather assessment: at least 3 months later, when the official 7-day mean air temperature is 27-35°C.
Secondary outcomes (1)
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.
Measured: Cold-weather assessment: after full recovery and at least 1 year after surgery, when the official 7-day mean air temperature is 0-8°C. Hot-weather assessment: at least 3 months later, when the official 7-day mean air temperature is 27-35°C.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start31 Jul 2024
- Primary completion10 Mar 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Berkay Girgin, Ankara Etlik City Hospital
- Investigators
- Ahmet Berkay Girgin, M.D., Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909760
- Sponsor's protocol ID
- Implant Pain in Cold
- Status last verified
- Nov 2026
- First submitted
- 17 Mar 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the results of this study will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Myth: Orthopaedic Implant Pain in Cold Weather
- ClinicalTrials.gov ID
- NCT06909760
- Acronym / sponsor ID
- Implant Pain in Cold
- Conditions
- Pain, Cold Temperature, Pain Catastrophizing, Cold Exposure
- Keywords
- pain, implant, cold weather, pain catastrophizing scale, orthopaedic implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material. 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. 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with orthopaedic implants | – | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-90 years with orthopaedic fracture implants.
Key inclusion criteria (1 listed)
- patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain on the extremity which was operated
Time frame: Cold-weather assessment: after full recovery and at least 1 year after surgery, when the official 7-day mean air temperature is 0-8°C. Hot-weather assessment: at least 3 months later, when the official 7-day mean air temperature is 27-35°C.
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.
1 secondary outcome
range of motion of the affected joints
Time frame: Cold-weather assessment: after full recovery and at least 1 year after surgery, when the official 7-day mean air temperature is 0-8°C. Hot-weather assessment: at least 3 months later, when the official 7-day mean air temperature is 27-35°C.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting the results of this study will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Berkay Girgin, M.D. principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Cold Temperature, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on the extremity which was operated (time frame: Cold-weather assessment: after full recovery and at least 1 year after surgery, when the official 7-day mean air temperature is 0-8°C. Hot-weather assessment: at least 3 months later, when the official 7-day mean air temperature is 27-35°C.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.