Trial Outcomes & Findings for chronOS Inject in Proximal Tibial Fractures (NCT NCT02056834)

NCT ID: NCT02056834

Last Updated: 2025-03-03

Results Overview

Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays

• Recruitment status: COMPLETED
• Target enrollment: 36 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-03-03

Participant Flow

Participant milestones

Measure	chronOS Inject Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Overall Study STARTED	36
Overall Study 6 Weeks	34
Overall Study 6 Months	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	chronOS Inject Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Overall Study Lost to Follow-up	7

Baseline Characteristics

chronOS Inject in Proximal Tibial Fractures

Baseline characteristics by cohort

Measure	chronOS Inject n=36 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Age, Continuous	55.4 years STANDARD_DEVIATION 14.6 • n=5 Participants
Age, Customized Age group <=58 years	19 participants n=5 Participants
Age, Customized Age group >58 years	17 participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	36 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	36 participants n=5 Participants
Smoking status Never	23 participants n=5 Participants
Smoking status Former	4 participants n=5 Participants
Smoking status Current	9 participants n=5 Participants
Height	163.4 cm STANDARD_DEVIATION 8.99 • n=5 Participants
Weight	62.6 kg STANDARD_DEVIATION 12.15 • n=5 Participants
Body mass index	23.3 kg/m2 STANDARD_DEVIATION 3.67 • n=5 Participants
Exercise per week Never	9 participants n=5 Participants
Exercise per week 1-2 times per week	21 participants n=5 Participants
Exercise per week 3-4 times per week	5 participants n=5 Participants
Exercise per week 5 or more times per week	1 participants n=5 Participants
Health status Excellent	4 participants n=5 Participants
Health status Good	28 participants n=5 Participants
Health status Fair	3 participants n=5 Participants
Health status Poor	0 participants n=5 Participants
Health status Missing	1 participants n=5 Participants
Occupation Student	3 participants n=5 Participants
Occupation Office worker	5 participants n=5 Participants
Occupation Home worker	7 participants n=5 Participants
Occupation Retired	6 participants n=5 Participants
Occupation Light industrial or light industrial labour	6 participants n=5 Participants
Occupation Moderate industrial or moderate physical labour	5 participants n=5 Participants
Occupation Other	4 participants n=5 Participants
Preoperative medical condition None	22 participants n=5 Participants
Preoperative medical condition Any	14 participants n=5 Participants
Preoperative medical conditions (description) Adiposity	1 participants n=5 Participants
Preoperative medical conditions (description) Allergies	0 participants n=5 Participants
Preoperative medical conditions (description) Cancer	0 participants n=5 Participants
Preoperative medical conditions (description) Cardiac	4 participants n=5 Participants
Preoperative medical conditions (description) Congenital	0 participants n=5 Participants
Preoperative medical conditions (description) Dermatological	1 participants n=5 Participants
Preoperative medical conditions (description) Endocrine	4 participants n=5 Participants
Preoperative medical conditions (description) Hematologic	0 participants n=5 Participants
Preoperative medical conditions (description) Implants/Prosthesis	0 participants n=5 Participants
Preoperative medical conditions (description) Infection	0 participants n=5 Participants
Preoperative medical conditions (description) Musculoskeletal including fractures	0 participants n=5 Participants
Preoperative medical conditions (description) Neurologic	1 participants n=5 Participants
Preoperative medical conditions (description) Psychiatric	0 participants n=5 Participants
Preoperative medical conditions (description) Respiratory	2 participants n=5 Participants
Preoperative medical conditions (description) Urogenital	0 participants n=5 Participants
Preoperative medical conditions (description) Vascular	3 participants n=5 Participants
Preoperative medical conditions (description) Other	3 participants n=5 Participants
Accident type Sport	1 participants n=5 Participants
Accident type Low energy	1 participants n=5 Participants
Accident type High energy	23 participants n=5 Participants
Accident type Direct blow	9 participants n=5 Participants
Accident type Fall from height	3 participants n=5 Participants
Accident type Simple fall	3 participants n=5 Participants
Accident type Motorcycle accident	4 participants n=5 Participants
Accident type Pedestrian in traffic accident	11 participants n=5 Participants
Accident type Car occupant in traffic accident	7 participants n=5 Participants
Accident type Other	2 participants n=5 Participants
Fracture type Schatzker Type I (lateral split)	1 participants n=5 Participants
Fracture type Schatzker Type II (split with depression)	14 participants n=5 Participants
Fracture type Schatzker Type III (pure lateral depression)	0 participants n=5 Participants
Fracture type Schatzker Type IV (pure medial depression)	2 participants n=5 Participants
Fracture type Schatzker Type V (bicondylar)	6 participants n=5 Participants
Fracture type Schatzker Type VI (split extends to metadiaphysis)	10 participants n=5 Participants
Fracture type AO-OTA 41 (proximal tibia fracture)	29 participants n=5 Participants
Fracture type AO-OTA 42 (diaphyseal tibia fracture)	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Fracture Union Union	27 participants
Fracture Union Non-union	2 participants

PRIMARY outcome

Timeframe: 12 months

Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Articular Subsidence Absent	28 participants
Articular Subsidence Present	1 participants

PRIMARY outcome

Timeframe: 12 months

Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function

Outcome measures

Measure	chronOS Inject n=34 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Mean Time to Union	7.5 months Standard Deviation 0.441

SECONDARY outcome

Timeframe: 12 months

Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Absorption Rate of Calcium Phosphate Cement	0.64 percentage of absorption at 12 months Standard Deviation 0.115

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Patients Who Reached Full Weight Bearing	29 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Total Range of Motion At least 140 degree	17 participants
Total Range of Motion At least 120 degree	11 participants
Total Range of Motion At least 90 degree	1 participants
Total Range of Motion At least 60 degree	0 participants
Total Range of Motion At least 30 degree	0 participants

SECONDARY outcome

Timeframe: 12 months

The following was assessed:

• depression of knee joint: presence or absence
• condylar widening (enlargement of the knee joint): presence or absence
• angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Anatomical Gradings Assessed Radiographically Absence of depression	28 participants
Anatomical Gradings Assessed Radiographically Absence of condylar widening	28 participants
Anatomical Gradings Assessed Radiographically Absence of angulation	29 participants

SECONDARY outcome

Timeframe: 12 months

Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Patient's Satisfaction	80.52 units on a scale Standard Deviation 16.02

SECONDARY outcome

Timeframe: Post-surgery

Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.

Outcome measures

Measure	chronOS Inject n=36 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Surgeon's Satisfaction With the Product Mixing ability	87.3 units on a scale Standard Deviation 6.16
Surgeon's Satisfaction With the Product Application time	87 units on a scale Standard Deviation 6.31
Surgeon's Satisfaction With the Product Setting time	77.1 units on a scale Standard Deviation 13.54
Surgeon's Satisfaction With the Product Injecting ability	87 units on a scale Standard Deviation 6.31
Surgeon's Satisfaction With the Product Moldability	81.7 units on a scale Standard Deviation 9.59
Surgeon's Satisfaction With the Product Rate of chronOS over bone graft	68.6 units on a scale Standard Deviation 28.39

SECONDARY outcome

Timeframe: 12 months

The following was assessed:

• extension ability of the knee
• stability of the knee in extension

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Extension Ability and Stability Normal extension ability	26 participants
Extension Ability and Stability 0-10 degree extension ability	3 participants
Extension Ability and Stability Normal extension stability	28 participants
Extension Ability and Stability Abnormal extension stability	1 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	chronOS Inject n=36 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Peri-operative Complications Microscopic or radiologic cement leakage during OP	0 participants
Peri-operative Complications Breakage of fixing device post-OP	0 participants
Peri-operative Complications Re-OP during hospital stay	0 participants
Peri-operative Complications Suffer from surgical wound complication post-OP	0 participants

SECONDARY outcome

Timeframe: 12 months

The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This 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.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
SF-12 Short Form Health Survey Physical Composite Score (PCS) Score at baseline	37.02 units on a scale Standard Deviation 9.616
SF-12 Short Form Health Survey Physical Composite Score (PCS) Score at 12 months	42.43 units on a scale Standard Deviation 4.589

SECONDARY outcome

Timeframe: 12 months

The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This 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.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
SF-12 Short Form Health Survey Mental Composite Score (MCS) Score at baseline	46.3 units on a scale Standard Deviation 9.707
SF-12 Short Form Health Survey Mental Composite Score (MCS) Score at 12 months	46.45 units on a scale Standard Deviation 7.145

SECONDARY outcome

Timeframe: 12 months

The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
VAS Leg Pain Intensity Score at baseline	61.19 units on a scale Standard Deviation 32.714
VAS Leg Pain Intensity Score at 12 months	17 units on a scale Standard Deviation 18.592

SECONDARY outcome

Timeframe: 12 months

The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
VAS Leg Pain Frequency Score at baseline	57.28 units on a scale Standard Deviation 33.505
VAS Leg Pain Frequency Score at 12 months	20.52 units on a scale Standard Deviation 20.051

SECONDARY outcome

Timeframe: 12 months

The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.

Outcome measures

Measure	chronOS Inject n=29 Participants Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
Lysholm Knee Scale Excellent (95-100)	14 participants
Lysholm Knee Scale Good (84-94)	11 participants
Lysholm Knee Scale Fair (65-83)	3 participants
Lysholm Knee Scale Poor (<65)	1 participants

Adverse Events

chronOS Inject

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	chronOS Inject n=36 participants at risk Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
Musculoskeletal and connective tissue disorders Non-union of lateral tibial condyle	2.8% 1/36 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.

Other adverse events

Measure	chronOS Inject n=36 participants at risk Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
Skin and subcutaneous tissue disorders K-wire irritation	8.3% 3/36 • Number of events 3 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Back pain	5.6% 2/36 • Number of events 2 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Volar mass on finger (MP joint)	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Articular subsidence, loss of reduction and depression of lateral condyle of the tibia	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
General disorders Pain	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Cartilage damage at the initial injury	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Posterior neck pain	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
Musculoskeletal and connective tissue disorders Non-union of lateral tibial condyle	2.8% 1/36 • Number of events 1 • Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.

Additional Information

Clinical Research Scientist Biomaterials

Synthes GmbH

Phone: 0041327204465

Email: clinicalaffairs.emea@synthes.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60