Pin Size Influence the Incidence of Knee Pain

Pain Clinical Trial

Official title:

Does Pin Size Influence the Incidence of Knee Pain in Patients Undergoing Temporary Skeletal Traction?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170480
• Other study ID #: 57624
• Status: Terminated
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female adults

• At least 18 years old

• Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS)	Questionaires to assess knee pain	Post-operative follow-up visits up to 1 year
Secondary	Short Musculoskeletal Function Questionnaire (SMFA)	Questionaire to assess musculoskeletal function	Post-operative follow-up visits up to 1 year