Pain Clinical Trial
Official title:
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Verified date | January 2018 |
Source | Orthopaedic Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 30, 2010 |
Est. primary completion date | April 30, 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is 18 years or older - Patient or legal representative is able to understand and provide signed consent for the procedure - Patient is willing and able to return for required follow-up visits - Patient needs a total hip arthroplasty surgical procedure Exclusion Criteria: - Patient has an active infection - Patient is enrolled in another similar study - Patient has a known history of hepatitis - Patient has a known history of HIV - Patient has a known history of AIDs - Patient has a known history of IV drug abuse |
Country | Name | City | State |
---|---|---|---|
United States | Indiana Orthopaedic Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Orthopaedic Research Foundation | OrthoIndy |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants With Incisional Drainage, Swelling or Gaps of Incision | Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters. | Discharge from initial hospital stay (2-5 days post-op) | |
Secondary | Participants With Wound Complications - Hematoma | Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not. | up to 6 weeks post-op |
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