N/A
N=60
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Erythema · Drainage · Bruising · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00940446 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Participants With Incisional Drainage, Swelling or Gaps of Incision — 10; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insorb staples (Device); metal staples (Ethicon metal stapler) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orthopaedic Research Foundation
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Incisional Drainage, Swelling or Gaps of Incision |
10; 16 | — |
| SECONDARY Participants With Wound Complications - Hematoma |
0; 1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00940446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.