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
1 other identifier
observational
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2014
CompletedFirst Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2017
CompletedSeptember 7, 2020
April 1, 2017
2.3 years
February 13, 2015
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone In-growth measured by CT scans
Bone In-growth measured by CT scans
1 year
Secondary Outcomes (5)
Bone In-growth measured by CT scans
6 months
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
Study Arms (1)
Observational
BIOSURE™ HEALICOIL™ PK Interference Screw
Interventions
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
Eligibility Criteria
Patients undergoing ACL reconstruction
You may qualify if:
- ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft.
- 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).
You may not qualify if:
- Revision ACL reconstruction
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32948982DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Lind, MD, PhD
Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2015
First Posted
March 6, 2015
Study Start
September 12, 2014
Primary Completion
January 4, 2017
Study Completion
January 4, 2017
Last Updated
September 7, 2020
Record last verified: 2017-04