PainNCT02170480
Pin Size Influence the Incidence of Knee Pain
An observational study of Pain, run by University of Utah at 1 site in United States.
Trial summary
It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the University of Utah Trauma and/or Orthopaedic Trauma services indicated for skeletal traction pin placement based on the presence of a femoral diaphyseal fracture and/or certain pelvic and acetabular fractures.
Who may be able to join
- Male and female adults
- At least 18 years old
- Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction.
Who cannot join
- Neurovascular compromise.
- Ipsilateral fractures presenting contraindication to skeletal traction
- Patients who are non-ambulatory.
- Patients less than 18 years of age.
- Patients who do not speak English.
- Ipsilateral ligamentous knee injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Pin Size Influence the Incidence of Knee Pain in Patients Undergoing Temporary Skeletal Traction?
It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Furthermore, no study has identified whether pin size has an effect on the incidence of postoperative knee pain. The goal of the present study is to establish whether use of temporary skeletal traction is associated with subsequent knee pain and to determine whether traction pin size influences the incidence and/or magnitude of knee pain.
Objective #1:
Read more
Determine whether pin size influences the incidence and/or severity of postoperative knee pain in patients who undergo temporary skeletal traction.
Hypothesis:
Larger traction pins are associated with an increase in both the incidence and severity of postoperative knee pain.
Objective#2:
Determine whether pin size affects musculoskeletal function in the postoperative period.
Hypothesis:
There is no difference between small and large traction pins in postoperative musculoskeletal function.
- Conditions
- Pain
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS)
Questionaires to assess knee pain
Measured: Post-operative follow-up visits up to 1 year
Secondary outcomes (1)
Short Musculoskeletal Function Questionnaire (SMFA)
Questionaire to assess musculoskeletal function
Measured: Post-operative follow-up visits up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: PI is moving to another university; resident researcher does not wish to continue study with another PI.
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 University of UtahThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Kubiak, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170480
- Sponsor's protocol ID
- 57624
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2014
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pin Size Influence the Incidence of Knee Pain in Patients Undergoing Temporary Skeletal Traction?
- ClinicalTrials.gov ID
- NCT02170480
- Acronym / sponsor ID
- 57624
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI is moving to another university; resident researcher does not wish to continue study with another PI.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- 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.
It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Furthermore, no study has identified whether pin size has an effect on the incidence of postoperative knee pain. The goal of the present study is to establish whether use of temporary skeletal traction is associated with subsequent knee pain and to determine whether traction pin size influences the incidence and/or magnitude of knee pain.
Objective #1:
Determine whether pin size influences the incidence and/or severity of postoperative knee pain in patients who undergo temporary skeletal traction.
Hypothesis:
Larger traction pins are associated with an increase in both the incidence and severity of postoperative knee pain.
Objective#2:
Determine whether pin size affects musculoskeletal function in the postoperative period.
Hypothesis:
There is no difference between small and large traction pins in postoperative musculoskeletal function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the University of Utah Trauma and/or Orthopaedic Trauma services indicated for skeletal traction pin placement based on the presence of a femoral diaphyseal fracture and/or certain pelvic and acetabular fractures.
Key inclusion criteria (3 listed)
- Male and female adults
- At least 18 years old
- Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction.
Key exclusion criteria (6 listed)
- Neurovascular compromise.
- Ipsilateral fractures presenting contraindication to skeletal traction
- Patients who are non-ambulatory.
- Patients less than 18 years of age.
- Patients who do not speak English.
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
2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS)
Time frame: Post-operative follow-up visits up to 1 year
Questionaires to assess knee pain
1 secondary outcome
Short Musculoskeletal Function Questionnaire (SMFA)
Time frame: Post-operative follow-up visits up to 1 year
Results and safety
The study was stopped early (reason given: PI is moving to another university; resident researcher does not wish to continue study with another PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Erik Kubiak, M.D. principal investigator
University of Utah
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, run by University of Utah at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 10 May 2023. 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 United States. 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 was stopped early (reason given: PI is moving to another university; resident researcher does not wish to continue study with another PI.). Results are not available in the source record.
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?
2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS) (time frame: Post-operative follow-up visits up to 1 year). 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 10 May 2023.