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Completed

NCT Number: NCT02382341

BIOSURE™ HEALICOIL™ PK Bone In-growth Study

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.

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Key information

Conditions

Deficiency of Anterior Cruciate Ligament

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOSURE™ HEALICOIL™ PK Interference Screw

Device

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

Primary outcomes

  1. Bone In-growth measured by CT scans

    Time frame: 1 year

    Bone In-growth measured by CT scans

Secondary outcomes

  1. Bone In-growth measured by CT scans

    Time frame: 6 months

    Bone In-growth measured by CT scans

  2. Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively

    Time frame: 1 year

  3. Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively

    Time frame: 1 year

  4. Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively

    Time frame: 2 years

  5. Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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