BIOSURE™ HEALICOIL™ PK Bone In-growth Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational BIOSURE™ HEALICOIL™ PK Interference Screw |
Device: BIOSURE™ HEALICOIL™ PK Interference Screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
|
Outcome Measures
Primary Outcome Measures
- Bone In-growth measured by CT scans [1 year]
Bone In-growth measured by CT scans
Secondary Outcome Measures
- Bone In-growth measured by CT scans [6 months]
Bone In-growth measured by CT scans
- Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively [1 year]
- Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively [1 year]
- Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively [2 years]
- Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively [2 Years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft.
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Willing and able to give voluntary informed consent to participate in this study
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Willing and able, in the opinion of the investigator, to cooperate with study procedures and willing to return to study site for all post-operative study visits.
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Subject is between 18 and 50 years at the time of surgery
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ASA group 0-2 (limited medical illness).
Exclusion Criteria:
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Revision ACL reconstruction
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Cartilage injury (IKDC Grade IV lesion> 2 cm2)
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Current malignant disease
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Rheumatoid arthritis
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Osteonecrosis or Avascular Necrosis
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Ankylosing spondylitis
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Subject is Obese; BMI > 35
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Subject is pregnant or plans to become pregnant during the study
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Subject has received medical treatment within 6 weeks of enrollment with any of the following:
Glucocorticoids Growth hormone
- Participating in another investigational trial or on-going study that would interfere with the assessment of the primary and secondary outcomes
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Principal Investigator: Martin Lind, MD, PhD, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15000946