BIOSURE™ HEALICOIL™ PK Bone In-growth Study

Deficiency of Anterior Cruciate Ligament Clinical Trial

Official title:

A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382341
• Other study ID #: 15000946
• Status: Completed
• Start date: September 12, 2014
• Est. completion date: January 4, 2017

Study information

• Verified date: April 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 4, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Deficiency of Anterior Cruciate Ligament

Intervention

Device:
• BIOSURE™ HEALICOIL™ PK Interference Screw
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone In-growth measured by CT scans	Bone In-growth measured by CT scans	1 year
Secondary	Bone In-growth measured by CT scans	Bone In-growth measured by CT scans	6 months
Secondary	Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively		1 year
Secondary	Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively		1 year
Secondary	Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively		2 years
Secondary	Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively		2 Years