Tibia FracturesNCT01282294

Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

An observational study of Tibia Fractures, run by Synthes GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tibia Fractures
What is being tested?: ETN PROtect
Type of treatment: Medical device
How many people: 100 participants
Where: 4 sitesGermany
Study dates: Feb 2011to Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients presenting to the ER with a tibia fracture

Who may be able to join

Adult patients aged 18 years or more
Open or closed tibia fracture according to the surgical technique

Who cannot join

Women who are pregnant or breast-feeding or are planning to become pregnant during the study
Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
Patients with a known allergy to aminoglycosides
Physical or mental incapacity, which makes it impossible to obtain informed consent
History of drug and alcohol abuse
Patient unlikely to cooperate
Legal incompetence

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

Charité - Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum Heidelberg
Heidelberg, 69120
University Hospital of Münster
Münster, 48149

Other trials in Germany

About this study

Official title: Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails

Conditions: Tibia Fractures
Being tested: ETN PROtect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ETN PROtectDevice
Expert Tibial Nail PROtect with Gentamicin coating

Study groups in NCT01282294
Study group	Role	What they receive
ETN PROtect		There is only 1 cohort in this case series Receives: Device: ETN PROtect

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life: SF-12 Physical Component Summary (PCS)
The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
It was administered at 3, 6, 12 and 18 months post-operatively.
Measured: 3, 6, 12 and 18 months post-operatively
Quality of Life: SF-12 Mental Component Summary (MCS)
The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
It was administered at 3, 6, 12 and 18 months post-operatively.
Measured: 3, 6, 12 and 18 months post-operatively
Quality of Life: EQ-5D
The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
Measured: 3, 6, 12 and 18 months post-operatively
Functional Outcome: IOWA Ankle Score
The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.
Measured: Baseline, 3, 6, 12 and 18 months post-operatively
Functional Outcome: WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.
Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations.
Measured: 3, 6, 12 and 18 months post-operatively
Infection Adverse Events
Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:
- superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue
- deep incisional SSI, affecting deep soft tissue
- organ/ space SSI (Osteomyelitis), affecting joint or bursa
Measured: 0 - 18 months

Secondary outcomes (9)

Evidence of Anatomic Bone Union According to Johnson Classification
Anatomic bone union was assessed according to Johnson et al.*:
A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Measured: 12 months
Evidence of Economic Bone Union According to Johnson Classification
Economic bone union was assessed according to Johnson et al.*:
E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Measured: 12 months
Evidence of Functional Bone Union According to Johnson Classification
Functional bone union was assessed according to Johnson et al.*:
F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.
*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57
Measured: 12 months
Surgeon's Perceived Satisfaction
Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).
Measured: 6 weeks, 3 and 6 months post-operatively
Likelihood to Develop Wound Infection Assessed by Surgeon
The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).
Measured: 6 weeks, 3 and 6 months post-operatively
Likelihood to Develop a Non-union Assessed by Surgeon
The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).
Measured: 6 weeks, 3 and 6 months post-operatively
Pain by Visual Analog Scale (VAS)
Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.
Measured: 6 weeks, 3, 6, 12 and 18 months post-operatively
Patient's Perceived Satisfaction
Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.
Measured: 6 months
Time to Full Weight Bearing
The time from surgery to full weight bearing was assessed in days.
Measured: 0 - 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Dec 2013

First posted24 Jan 2011 (estimated)
Study startFeb 2011
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tibia FracturesStudies 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: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01282294
Sponsor's protocol ID: STU-BIO-T-XX-190-02
Status last verified: Feb 2015
First submitted: 21 Jan 2011
Last updated: 17 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

All Tibia Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails
ClinicalTrials.gov ID: NCT01282294
Acronym / sponsor ID: STU-BIO-T-XX-190-02
Conditions: Tibia Fractures
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Synthes GmbHIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 24 Jan 2011 (estimated)
Results: Posted 11 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
ETN PROtect	–	Device: ETN PROtectThere is only 1 cohort in this case series

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients presenting to the ER with a tibia fracture

Key inclusion criteria (2 listed)

Adult patients aged 18 years or more
Open or closed tibia fracture according to the surgical technique

Key exclusion criteria (7 listed)

Women who are pregnant or breast-feeding or are planning to become pregnant during the study
Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
Patients with a known allergy to aminoglycosides
Physical or mental incapacity, which makes it impossible to obtain informed consent
History of drug and alcohol abuse

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
ETN PROtectExpert Tibial Nail PROtect with Gentamicin coating	Device	ETN PROtect

Primary outcome

Quality of Life: SF-12 Physical Component Summary (PCS)
Time frame: 3, 6, 12 and 18 months post-operatively
The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Quality of Life: SF-12 Mental Component Summary (MCS)
Time frame: 3, 6, 12 and 18 months post-operatively
The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Quality of Life: EQ-5D
Time frame: 3, 6, 12 and 18 months post-operatively
The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
Functional Outcome: IOWA Ankle Score
Time frame: Baseline, 3, 6, 12 and 18 months post-operatively
The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.
Functional Outcome: WOMAC
Time frame: 3, 6, 12 and 18 months post-operatively
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations.
Infection Adverse Events
Time frame: 0 - 18 months
Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into: * superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue * deep incisional SSI, affecting deep soft tissue * organ/ space SSI (Osteomyelitis), affecting joint or bursa

9 secondary outcomes

Evidence of Anatomic Bone Union According to Johnson Classification
Time frame: 12 months
Evidence of Economic Bone Union According to Johnson Classification
Time frame: 12 months
Evidence of Functional Bone Union According to Johnson Classification
Time frame: 12 months
Surgeon's Perceived Satisfaction
Time frame: 6 weeks, 3 and 6 months post-operatively
Likelihood to Develop Wound Infection Assessed by Surgeon
Time frame: 6 weeks, 3 and 6 months post-operatively
Likelihood to Develop a Non-union Assessed by Surgeon
Time frame: 6 weeks, 3 and 6 months post-operatively
Pain by Visual Analog Scale (VAS)
Time frame: 6 weeks, 3, 6, 12 and 18 months post-operatively
Patient's Perceived Satisfaction
Time frame: 6 months
Time to Full Weight Bearing
Time frame: 0 - 18 months

Results and safety

Results posted to the registry on 11 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ETN PROtect	100	81

Primary outcome: Quality of Life: SF-12 Physical Component Summary (PCS)

Time frame: 3, 6, 12 and 18 months post-operatively. Mean (Standard Deviation). Unit: scores on a scale

Measure	ETN PROtect n = 89
Score at 3 months, n=74	36.9 (10.0)
Score at 6 months, n=82	41.2 (9.3)
Score at 12 months, n=74	45.6 (9.1)
Score at 18 months, n=68	44.6 (10.7)

Population analysed: Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).

Primary outcome: Quality of Life: SF-12 Mental Component Summary (MCS)

Time frame: 3, 6, 12 and 18 months post-operatively. Mean (Standard Deviation). Unit: scores on a scale

Measure	ETN PROtect n = 89
Score at 3 months, n=74	52.7 (10.8)
Score at 6 months, n=82	53.2 (10.3)
Score at 12 months, n=74	53.3 (9.9)
Score at 18 months, n=68	53.1 (10.2)

Primary outcome: Quality of Life: EQ-5D

Time frame: 3, 6, 12 and 18 months post-operatively. Mean (Standard Deviation). Unit: scores on a scale

Measure	ETN PROtect n = 89
Score at 3 months, n=78	0.7 (0.2)
Score at 6 months, n=83	0.8 (0.2)
Score at 12 months, n=78	0.8 (0.2)
Score at 18 months, n=72	0.9 (0.1)

Primary outcome: Functional Outcome: IOWA Ankle Score

Time frame: Baseline, 3, 6, 12 and 18 months post-operatively. Mean (Standard Deviation). Unit: scores on a scale

Measure	ETN PROtect n = 89
Score at Baseline, n=52	86.3 (25.7)
Score at 3 months, n=77	62.9 (20.1)
Score at 6 months, n=84	76.4 (19.6)
Score at 12 months, n=77	81.2 (20.3)
Score at 18 months, n=73	85.2 (18.6)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ETN PROtect	38 of 99 (38.4%)	49 of 99 (49.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tibia Fractures

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

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.

Michael J. Raschke, MD principal investigator

University Hospital of Münster, Germany

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tibia Fractures, run by Synthes GmbH at 4 sites in Germany.

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 2 inclusion and 7 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Quality of Life: SF-12 Physical Component Summary (PCS) (time frame: 3, 6, 12 and 18 months post-operatively). The study lists 6 primary outcomes in all. 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 NCT01282294.

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 17 Mar 2015.