Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2014-09-12
2017-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational
BIOSURE™ HEALICOIL™ PK Interference Screw
BIOSURE™ HEALICOIL™ PK Interference Screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
Interventions
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BIOSURE™ HEALICOIL™ PK Interference Screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
Eligibility Criteria
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Inclusion Criteria
* Willing and able to give voluntary informed consent to participate in this study
* 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.
* Subject is between 18 and 50 years at the time of surgery
* ASA group 0-2 (limited medical illness).
Exclusion Criteria
* Cartilage injury (IKDC Grade IV lesion\> 2 cm2)
* Current malignant disease
* Rheumatoid arthritis
* Osteonecrosis or Avascular Necrosis
* Ankylosing spondylitis
* Subject is Obese; BMI \> 35
* Subject is pregnant or plans to become pregnant during the study
* 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
18 Years
50 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Lind, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
References
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Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z.
Other Identifiers
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15000946
Identifier Type: -
Identifier Source: org_study_id
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