Trials / Completed
CompletedNCT02382341
BIOSURE™ HEALICOIL™ PK Bone In-growth Study
A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.
Detailed description
The primary objective of the current study is to assess bone in-growth in the BIOSURE™ HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will also be documented.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BIOSURE™ HEALICOIL™ PK Interference Screw | Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw |
Timeline
- Start date
- 2014-09-12
- Primary completion
- 2017-01-04
- Completion
- 2017-01-04
- First posted
- 2015-03-06
- Last updated
- 2020-09-07
Source: ClinicalTrials.gov record NCT02382341. Inclusion in this directory is not an endorsement.