BIOSURE™ HEALICOIL™ PK Bone In-growth Study

Completed

• Conditions: Deficiency of Anterior Cruciate Ligament
• Interventions: Device: BIOSURE™ HEALICOIL™ PK Interference Screw

• Registration Number: NCT02382341
• Lead Sponsor: Smith & Nephew, Inc.

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.

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 Timeline

• Study Start: 2014-09-12
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-04
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	BIOSURE™ HEALICOIL™ PK Interference Screw	BIOSURE™ HEALICOIL™ PK Interference Screw

Primary Outcome Measures

Name	Time	Method
Bone In-growth measured by CT scans	1 year	Bone In-growth measured by CT scans

Secondary Outcome Measures

Name	Time	Method
Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively	1 year
Bone In-growth measured by CT scans	6 months	Bone In-growth measured by CT scans
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