CompletedNot Applicable

BIOSURE™ HEALICOIL™ PK Bone In-growth Study

12 participantsStarted 2014-09-12

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bone In-growth measured by CT scans

Timeframe: 1 year

Trial details

NCT IDNCT02382341

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-01-04

View on ClinicalTrials.gov More Deficiency of Anterior Cruciate Ligament trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.