BIOSURE™ HEALICOIL™ PK Bone In-growth Study

September 3, 2020 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ACL reconstruction

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone In-growth measured by CT scans
Time Frame: 1 year
Bone In-growth measured by CT scans
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone In-growth measured by CT scans
Time Frame: 6 months
Bone In-growth measured by CT scans
6 months
Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively
Time Frame: 1 year
1 year
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively
Time Frame: 1 year
1 year
Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively
Time Frame: 2 years
2 years
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Martin Lind, MD, PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2014

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

January 4, 2017

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15000946

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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