Trial Outcomes & Findings for Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures (NCT NCT01282294)

Last Updated: 2015-03-17

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

3, 6, 12 and 18 months post-operatively

Results posted on

2015-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	ETN PROtect ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Overall Study STARTED	100
Overall Study Intra-operative	99
Overall Study Post-operative	99
Overall Study 6 Weeks	95
Overall Study 3 Months	95
Overall Study 6 Months	94
Overall Study 12 Months	86
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	ETN PROtect ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Overall Study Lost to Follow-up	14
Overall Study Screening failure	1
Overall Study Adverse Event	1
Overall Study Patient non-compliance	2
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ETN PROtect n=99 Participants There is only 1 cohort in this case series. ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating
Drugs Drug abuser	0 participants n=5 Participants
Drugs Ex-drug abuser	15 participants n=5 Participants
Fracture type traumatic/pathologic	68 participants n=5 Participants
Fracture type revision purposes	31 participants n=5 Participants
Fracture type (open or closed) Open	45 participants n=5 Participants
Fracture type (open or closed) Closed	50 participants n=5 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	97 participants n=5 Participants
Race/Ethnicity, Customized Negroid	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants
Region of Enrollment Germany	99 participants n=5 Participants
Body Mass Index (BMI)	26.2 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants
Height	177.6 cm STANDARD_DEVIATION 8.6 • n=5 Participants
Weight	82.8 kg STANDARD_DEVIATION 18.7 • n=5 Participants
Allergies No or unknown	74 participants n=5 Participants
Allergies Metal	2 participants n=5 Participants
Allergies Gentamicin	0 participants n=5 Participants
Allergies Other	23 participants n=5 Participants
Smoking Yes	31 participants n=5 Participants
Smoking No, quit <= 6 Months ago	4 participants n=5 Participants
Smoking No, quit > 6 Months ago	19 participants n=5 Participants
Smoking No, never smoked	45 participants n=5 Participants
Drinking Never drank	22 participants n=5 Participants
Drinking Drinks small amounts (<3 units/day)	76 participants n=5 Participants
Drinking Drinker	0 participants n=5 Participants
Drinking Ex-drinker	1 participants n=5 Participants
Drugs Never used drugs	84 participants n=5 Participants
Fracture type (open or closed) None	1 participants n=5 Participants
Fracture type (open or closed) Unknown	3 participants n=5 Participants
Time from injury to surgery for traumatic/pathologic patients	8.7 days STANDARD_DEVIATION 28.5 • n=5 Participants
Time from injury to surgery for revision patients	17.1 months STANDARD_DEVIATION 16.5 • n=5 Participants
Use of systemic antibiotics prophylaxis Pre-Operative	28 participants n=5 Participants
Use of systemic antibiotics prophylaxis Peri-Operative	76 participants n=5 Participants
Use of systemic antibiotics prophylaxis Post-Operative	32 participants n=5 Participants
Use of systemic antibiotics prophylaxis None	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 3, 6, 12 and 18 months post-operatively

Population: 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).

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Quality of Life: SF-12 Physical Component Summary (PCS) Score at 3 months, n=74	36.9 scores on a scale Standard Deviation 10.0
Quality of Life: SF-12 Physical Component Summary (PCS) Score at 6 months, n=82	41.2 scores on a scale Standard Deviation 9.3
Quality of Life: SF-12 Physical Component Summary (PCS) Score at 12 months, n=74	45.6 scores on a scale Standard Deviation 9.1
Quality of Life: SF-12 Physical Component Summary (PCS) Score at 18 months, n=68	44.6 scores on a scale Standard Deviation 10.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Quality of Life: SF-12 Mental Component Summary (MCS) Score at 3 months, n=74	52.7 scores on a scale Standard Deviation 10.8
Quality of Life: SF-12 Mental Component Summary (MCS) Score at 6 months, n=82	53.2 scores on a scale Standard Deviation 10.3
Quality of Life: SF-12 Mental Component Summary (MCS) Score at 12 months, n=74	53.3 scores on a scale Standard Deviation 9.9
Quality of Life: SF-12 Mental Component Summary (MCS) Score at 18 months, n=68	53.1 scores on a scale Standard Deviation 10.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Quality of Life: EQ-5D Score at 18 months, n=72	0.9 scores on a scale Standard Deviation 0.1
Quality of Life: EQ-5D Score at 3 months, n=78	0.7 scores on a scale Standard Deviation 0.2
Quality of Life: EQ-5D Score at 6 months, n=83	0.8 scores on a scale Standard Deviation 0.2
Quality of Life: EQ-5D Score at 12 months, n=78	0.8 scores on a scale Standard Deviation 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Functional Outcome: IOWA Ankle Score Score at 18 months, n=73	85.2 scores on a scale Standard Deviation 18.6
Functional Outcome: IOWA Ankle Score Score at Baseline, n=52	86.3 scores on a scale Standard Deviation 25.7
Functional Outcome: IOWA Ankle Score Score at 3 months, n=77	62.9 scores on a scale Standard Deviation 20.1
Functional Outcome: IOWA Ankle Score Score at 6 months, n=84	76.4 scores on a scale Standard Deviation 19.6
Functional Outcome: IOWA Ankle Score Score at 12 months, n=77	81.2 scores on a scale Standard Deviation 20.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Functional Outcome: WOMAC Score at 3 months, n=80	29.3 scores on a scale Standard Deviation 18.5
Functional Outcome: WOMAC Score at 6 months, n=84	24.6 scores on a scale Standard Deviation 19.1
Functional Outcome: WOMAC Score at 12 months, n=76	19.2 scores on a scale Standard Deviation 19.5
Functional Outcome: WOMAC Score at 18 months, n=73	18.2 scores on a scale Standard Deviation 20.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Infection Adverse Events superficial incisional SSI at site of ETN PROtect	6 number of events
Infection Adverse Events deep incisional SSI at site of ETN PROtect	5 number of events
Infection Adverse Events organ/ space SSI at site of ETN PROtect	0 number of events

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	ETN PROtect n=78 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Evidence of Anatomic Bone Union According to Johnson Classification A0	4 participants
Evidence of Anatomic Bone Union According to Johnson Classification A1	2 participants
Evidence of Anatomic Bone Union According to Johnson Classification A2	9 participants
Evidence of Anatomic Bone Union According to Johnson Classification A3	11 participants
Evidence of Anatomic Bone Union According to Johnson Classification A4	52 participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	ETN PROtect n=78 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Evidence of Economic Bone Union According to Johnson Classification E0	3 participants
Evidence of Economic Bone Union According to Johnson Classification E1	19 participants
Evidence of Economic Bone Union According to Johnson Classification E2	8 participants
Evidence of Economic Bone Union According to Johnson Classification E3	8 participants
Evidence of Economic Bone Union According to Johnson Classification E4	40 participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	ETN PROtect n=78 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Evidence of Functional Bone Union According to Johnson Classification F0	4 participants
Evidence of Functional Bone Union According to Johnson Classification F1	1 participants
Evidence of Functional Bone Union According to Johnson Classification F2	24 participants
Evidence of Functional Bone Union According to Johnson Classification F3	17 participants
Evidence of Functional Bone Union According to Johnson Classification F4	32 participants

SECONDARY outcome

Timeframe: 6 weeks, 3 and 6 months post-operatively

Surgeons' perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Surgeon's Perceived Satisfaction Score at 6 weeks, n=84	18.2 scores on a scale Standard Deviation 15.9
Surgeon's Perceived Satisfaction Score at 3 months, n=82	18.9 scores on a scale Standard Deviation 16.8
Surgeon's Perceived Satisfaction Score at 6 months, n=84	14.9 scores on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: 6 weeks, 3 and 6 months post-operatively

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).

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Likelihood to Develop Wound Infection Assessed by Surgeon Score at 6 months, n=84	14.4 scores on a scale Standard Deviation 19.1
Likelihood to Develop Wound Infection Assessed by Surgeon Score at 6 weeks, n=84	19.6 scores on a scale Standard Deviation 19.6
Likelihood to Develop Wound Infection Assessed by Surgeon Score at 3 months, n=82	14.6 scores on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: 6 weeks, 3 and 6 months post-operatively

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).

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Likelihood to Develop a Non-union Assessed by Surgeon Score at 6 weeks, n=84	26.4 scores on a scale Standard Deviation 19.1
Likelihood to Develop a Non-union Assessed by Surgeon Score at 3 months, n=82	23.0 scores on a scale Standard Deviation 17.7
Likelihood to Develop a Non-union Assessed by Surgeon Score at 6 months, n=84	19.6 scores on a scale Standard Deviation 21.5

SECONDARY outcome

Timeframe: 6 weeks, 3, 6, 12 and 18 months post-operatively

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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=89 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Pain by Visual Analog Scale (VAS) Score at 6 weeks, n=82	19.3 scores on a scale Standard Deviation 17.4
Pain by Visual Analog Scale (VAS) Score at 3 months, n=81	24.3 scores on a scale Standard Deviation 16.2
Pain by Visual Analog Scale (VAS) Score at 6 months, n=84	27.0 scores on a scale Standard Deviation 21.2
Pain by Visual Analog Scale (VAS) Score at 12 months, n=78	21.0 scores on a scale Standard Deviation 16.3
Pain by Visual Analog Scale (VAS) Score at 18 months, n=73	23.0 scores on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	ETN PROtect n=84 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Patient's Perceived Satisfaction	63.8 scores on a scale Standard Deviation 26.7

SECONDARY outcome

Timeframe: 0 - 18 months

The time from surgery to full weight bearing was assessed in days.

Outcome measures

Outcome measures
Measure	ETN PROtect n=85 Participants ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Time to Full Weight Bearing	90.0 days Interval 41.0 to 393.0

Adverse Events

ETN PROtect

Serious events: 38 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ETN PROtect n=99 participants at risk ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Musculoskeletal and connective tissue disorders BACK PAIN AGGRAVATED	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders COXARTHRITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders DEVICE BREAKAGE	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders DISORDERS OF MUSCLE, LIGAMENT, AND FASCIA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders ECTOPIC OSSIFICATION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications FALL	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications FIBULA FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders FISTULA	3.0% 3/99 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders FRACTURE DELAYED UNION	5.1% 5/99 • Number of events 6 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders FRACTURE MALUNION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders FRACTURE NONUNION	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders HAMMER TOE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Cardiac disorders HEART ATTACK	1.0% 1/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Vascular disorders HEMATOMA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications HUMERUS FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders LOCAL SWELLING	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations LOCALIZED INFECTION	3.0% 3/99 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders LOSS OF RANGE OF MOTION ASSOCIATED WITH DEVICE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders MEDICAL DEVICE COMPLICATION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders NONUNION OF FRACTURE	5.1% 5/99 • Number of events 5 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations OSTEOMYELITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders PAIN IN FOOT	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations POST-OPERATIVE WOUND INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders PSEUDARTHROSIS	1.0% 1/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Psychiatric disorders PSYCHOSIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Skin and subcutaneous tissue disorders SKIN NECROSIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders SOFT TISSUE NECROSIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations SURGICAL WOUND INFECTION	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders SWELLING	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Vascular disorders THROMBOSIS LEG	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations URINARY TRACT INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications WOUND DEHISCENCE	3.0% 3/99 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders WOUND HEALING DISTURBANCE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations WOUND INFECTION	1.0% 1/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Blood and lymphatic system disorders Anemia	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.

Other adverse events

Other adverse events
Measure	ETN PROtect n=99 participants at risk ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
Immune system disorders ALLERGIC REACTION	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders BONE FRACTURE SPONTANEOUS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders BONE FRAGILE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications BONE FRAGMENTATION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations BRONCHITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications BRUISE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders CALF PAIN	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders CHONDROPATHY	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders COXARTHROSIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders COXITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Vascular disorders DEEP VEIN THROMBOSIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Psychiatric disorders DEPRESSION WORSENED(	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Psychiatric disorders DEPRESSIVE EPISODE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders DEVICE POSITIONED INAPPROPRIATELY	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Gastrointestinal disorders DUODENITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Skin and subcutaneous tissue disorders ERYTHEMA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders FRACTURE DELAYED UNION	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Gastrointestinal disorders GASTRITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations GASTROINTESTINAL INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders HALLUX VALGUS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders HEALING DELAYED	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Vascular disorders HEMATOMA	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders IMPINGEMENT SYNDROME	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations INFLUENZA	3.0% 3/99 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders KNEE PAIN	4.0% 4/99 • Number of events 4 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders LOCAL SWELLING	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Vascular disorders LYMPHEDEMA	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Nervous system disorders NEUROPATHY	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Metabolism and nutrition disorders NON-INSULIN-DEPENDENT DIABETES MELLITUS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders NONUNION OF FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Nervous system disorders NUMBNESS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Nervous system disorders NUMBNESS IN LEG	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications OPERATION SITE BLEED	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations OSTEOMYELITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders PAIN	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders PAIN IN FOOT	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Nervous system disorders PARASTHESIA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders PATELLAR TENDINITIS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications PERIPROSTHETIC FRACTURE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations PNEUMONIA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Nervous system disorders POLYNEUROPATHY	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Psychiatric disorders PROLONGED POSTTRAUMATIC STRESS DISORDER	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations SKIN INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Skin and subcutaneous tissue disorders SKIN LESION NOS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Skin and subcutaneous tissue disorders SKIN NECROSIS(	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications STRESS FRACTURE	1.0% 1/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications SUBLUXATION PATELLA	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations SURGICAL WOUND INFECTION	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Injury, poisoning and procedural complications SUTURE GRANULOMA	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders SWELLING	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders SWELLING OF LEGS	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders TIBIA PAIN	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Gastrointestinal disorders TOOTHACHE	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Musculoskeletal and connective tissue disorders UNEQUAL LEG LENGTH (ACQUIRED)	3.0% 3/99 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Renal and urinary disorders URINARY TRACT DISORDER	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations URINARY TRACT INFECTION	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
Infections and infestations WHITLOW	1.0% 1/99 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.
General disorders WOUND HEALING DISTURBANCE	2.0% 2/99 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 18 months.

Additional Information

Clinical Research Scientist

Synthes GmbH

Phone: 0041 32 720 44 65

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A single comprehensive publication may be authored on the procedure and outcomes of the trial. Sites that enroll less than five patients will not be included in the publication. Synthes GmbH will have the right to review prior to submission. Each clinical site that enrolls ten patients will have the option to submit an abstract for publication or presentation at a regional, national, or international conference on their work. Synthes GmbH will have the right to review prior to submission.
Publication restrictions are in place

Restriction type: OTHER