Deficiency of Anterior Cruciate LigamentNCT02382341
BIOSURE™ HEALICOIL™ PK Bone In-growth Study
An observational study of Deficiency of Anterior Cruciate Ligament, run by Smith & Nephew, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Deficiency of Anterior Cruciate Ligament
- What is being tested?
- BIOSURE™ HEALICOIL™ PK Interference Screw
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2014to 4 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing ACL reconstruction
Who may be able to join
- 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).
Who cannot join
- Revision ACL reconstruction
- Cartilage injury (IKDC Grade IV lesion> 2 cm2)
- Current malignant disease
- Rheumatoid arthritis
- Osteonecrosis or Avascular Necrosis
- Ankylosing spondylitis
Show all 11Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Deficiency of Anterior Cruciate Ligament
- Being tested
- BIOSURE™ HEALICOIL™ PK Interference Screw
- Keywords
- ACL, BIOSURE, HEALICOIL, PEEK, In-Growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOSURE™ HEALICOIL™ PK Interference ScrewDevice
Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
| Study group | Role | What they receive |
|---|---|---|
| Observational | BIOSURE™ HEALICOIL™ PK Interference Screw Receives: Device: BIOSURE™ HEALICOIL™ PK Interference Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone In-growth measured by CT scans
Bone In-growth measured by CT scans
Measured: 1 year
Secondary outcomes (5)
Bone In-growth measured by CT scans
Bone In-growth measured by CT scans
Measured: 6 months
Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively
Measured: 1 year
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively
Measured: 1 year
Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively
Measured: 2 years
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start12 Sep 2014
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deficiency of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Lind, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382341
- Sponsor's protocol ID
- 15000946
- Status last verified
- Apr 2017
- First submitted
- 13 Feb 2015
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z.
PubMed 32948982
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation
- ClinicalTrials.gov ID
- NCT02382341
- Acronym / sponsor ID
- 15000946
- Conditions
- Deficiency of Anterior Cruciate Ligament
- Keywords
- ACL, BIOSURE, HEALICOIL, PEEK, In-Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Device: BIOSURE™ HEALICOIL™ PK Interference ScrewBIOSURE™ HEALICOIL™ PK Interference Screw |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing ACL reconstruction
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- Revision ACL reconstruction
- Cartilage injury (IKDC Grade IV lesion> 2 cm2)
- Current malignant disease
- Rheumatoid arthritis
- Osteonecrosis or Avascular Necrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOSURE™ HEALICOIL™ PK Interference ScrewSubjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw | Device | Observational |
Primary outcome
Bone In-growth measured by CT scans
Time frame: 1 year
Bone In-growth measured by CT scans
5 secondary outcomes
Bone In-growth measured by CT scans
Time frame: 6 months
Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively
Time frame: 1 year
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively
Time frame: 1 year
Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively
Time frame: 2 years
Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Derived from this study: PubMed 32948982Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lind, MD, PhD principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Deficiency of Anterior Cruciate Ligament, run by Smith & Nephew, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone In-growth measured by CT scans (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.