N/A
Completed N=41
Zip Arthroplasty Patient Satisfaction Evaluation
Source: ClinicalTrials.gov NCT03178266 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
May 2019
Primary outcomePrimary: Patient and Observer Scar Assessment Scale (POSAS) — 2.25; 3.40; 1.10; 2.29 score on a scale
Summary
This study is a prospective, randomized, single center, study to evaluate Zip Closure Device in subjects undergoing knee arthroplasty. Patients identified as candidates for knee arthroplasty and meet the study selection criteria will be approached and considered for the study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive ZipLine and 20 subjects will receive Staples.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient and Observer Scar Assessment Scale (POSAS) |
2.25; 3.40; 1.10; 2.29 | — |
| SECONDARY Patient Satisfaction |
1.45; 1.94 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary elective knee arthroplasty.
- Willing and able to provide informed consent and/or obtain legal guardian authorization
- Willing and able to comply with the subject-specific requirements outlined in the study protocol
Exclusion Criteria
- Patients that do not meet the conditions listed in the wound closure device warnings, precautions, and contraindications (Appendix A)
- Patients with comorbidities or conditions that the investigator deems to be ineligible for the study
- Patients without the capacity to give informed consent (e.g., dementia)
Data sourced from ClinicalTrials.gov (NCT03178266). 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. Informational only — not medical advice.