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Trial registered on ANZCTR


Registration number
ACTRN12613000649718
Ethics application status
Not yet submitted
Date submitted
23/04/2013
Date registered
11/06/2013
Date last updated
24/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
PRECICE 8.5mm First in Man Study - Intramedullary Limb Lengthening for Patients with a Unilateral Leg Length Discrepancy
Scientific title
First in Man Study - A Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the PRECICE 8.5mm Intramedullary Limb Lengthening System with Leg Length Discrepancy Due to a Short Femur or Tibia
Secondary ID [1] 282386 0
Nil known
Universal Trial Number (UTN)
U1111-1142-0875
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limb length discrepancy 288967 0
Condition category
Condition code
Musculoskeletal 289303 289303 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PRECICE 8.5mm Intramedullary Limb Lengthening (IMLL) System is indicated for limb lengthening of the tibia and femur. It is composed of an implantable intramedullary device (“IMLL Device”), locking screws, an external remote controller (“ERC”), and reusable instruments. The implantable IMLL Device is available in different configurations and lengths to accommodate a variety of patient anatomies.

The PRECICE 8.5mm IMLL System is implanted with a minimally-invasive surgical procedure identical to that of the commercially-approved PRECICE system and similar to other intramedullary limb lengthening devices. The Distraction Phase (lengthening phase) begins after an appropriate latency interval, typically 5 days after surgery.

During Distraction Phase, the device is lengthened (typically 1mm per day) until the desired length is achieved depending upon each individual patient's leg length discrepancy.

Consolidation Phase begins immediately after distraction phase and ends upon radiographic verification of union (corticalization of bone regenerate observed on 3 sides of the treat bone). Subjects return for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. As with the Distraction Phase, the Consolidation Phase will differ for each patient according to their treatment program as defined by their physician.
Intervention code [1] 287018 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289414 0
Adverse events due to the PRECICE 8.5mm IMLL System.

A list of known/possible adverse events with the PRECICE 8.5mm System are as follows:

1. Death
2. Adverse reaction to device materials
3. Infection
4. Pain and loss of function
a. Soft tissue tension
b. Muscle tightness
c. Join stiffness
d. Temporary loss of motion
e. Contracture
f. Loss of alignment
g. Loss of range of motion
5. Revision
6. Implant Failure
7. Distraction Failure
a. Premature bone consolidation during distraction osteogenesis
b. Lack of osteogenic distraction
c. Failure to achieve desired limb length/over lengthen
d. Poor bone quality regenerate
e. Fracture of regenerate bone
f. Delayed or non-union at the osteotomy site
8. Surgical Complications
a. Nerve or vessel damage resulting in insertion in the intramedullary canal
b. Edema or swelling, possible compartment syndrome, wound or bine infection
c. Pulmonary embolism
d. Thrombophlebitis
e. Wound hematoma
f. Avascular necrosis
g. Tissue damage
Timepoint [1] 289414 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Primary outcome [2] 289415 0
Bone Union assessed via x-ray
Timepoint [2] 289415 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Secondary outcome [1] 302420 0
Quality of the regenerate bone assessed via x-ray.
Timepoint [1] 302420 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Secondary outcome [2] 302421 0
Medication Usage - All Prescribed Medications assessed via review of subject medical records.
Timepoint [2] 302421 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Secondary outcome [3] 302422 0
Healing Index assessed via subject medical records.
Timepoint [3] 302422 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Secondary outcome [4] 302423 0
Number of days to complete lengthening assessed via x-ray.
Timepoint [4] 302423 0
Through Distraction Phase (the time period where the treated bone is lengthened and ends upon achieving the targeted length).
Secondary outcome [5] 302424 0
Number of days to full weight bearing. This will be assessed by the study doctor via radiographic review of the treated bone.
Timepoint [5] 302424 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.
Secondary outcome [6] 302425 0
Number of days to full consolidation assessed via x-ray.
Timepoint [6] 302425 0
Subjects will be followed through consolidation of their treated limb which is defined as radiographic verification of union with regenerate corticalization on 3 sides of the treated bone.

Participants will return to their study doctor's office for study follow-up examinations every 4 to 6 weeks during Consolidation Phase. A physical examination and x-ray will be performed.

Eligibility
Key inclusion criteria
1. Leg length discrepancy greater than or equal to 1.5 cm and less than or equal to 8.0 cm due to short femur or tibia
2. Age greater than or equal to 7 years old
3. Weight less than or equal to 68 kg
4. Intramedullary canal without offset
5. Tibia or femur sufficient to contain the implant
6. Availability, willingness, and sufficient cognitive awareness to comply with protocol procedures and schedule
7. Must sign informed consent to permit the use of personal health data
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active infection or previous history of deep infection in the involved bone
2. Metal allergies or sensitivities to the components of the device
3. Distance from the nearest convenient external surface of the treated limb to the intramedullary canal < 51 mm
4. Significant range of motion deficit of the adjacent joints
5. Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic or magnetic implant
6. Patients who require an MRI during implantation
7. Non-union
8. Impassable or obstructed intramedullary canal
9. Significant angular deformity that prevents device placement
10. Cannot bear weight on the contralateral limb
11. Procedural osteotomy cannot be made in an appropriate location
12. Deformities that require multilevel osteotomies or bi-lateral implantation at the time of study index surgery
13. Systemic bone disease
14. Pregnant or nursing women
15. Inadequate vascularity or evidence of vascular disease or peripheral neuropathy
16. Malignancies or tumors in the involved bone
17. Patient is a drug abuser
18. Open wounds or ulcers that could compromise treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treating surgeon and his staff will pre-screen patients to determine eligibility. The treating surgeon will meet with the qualifying patient to introduce the study, provide the informed consent document, and answer any questions the patient may have. After all of patient's questions have been answered and the patient would like to proceed with participation, the informed consent document is signed by the treating surgeon, patient, and patient's parents or legal guardian as applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis
Data collected in this study will be summarized using tables, graphs and patient data listings. Demographic, safety data and primary and secondary endpoints will be summarized. Descriptive statistics will be provided for every variable. Descriptive statistics for continuous variables will include mean, standard deviation, range and sample size. Categorical variables will be summarized with percentages based on an exact binomial distribution.
Baseline characteristics will include patient age, gender, weight, height, and cause of discrepancy. Descriptive statistics will be presented for all baseline characteristics.
The incidence of all adverse events will be reported descriptively with number of events, number of subjects having one or more events, percentages and sample size. Adverse events will be characterized by their relatedness to the study procedure and/or the study device. Procedure-related adverse events occurring during implantation and during the distraction visits will be presented separately.

Due to the feasibility nature of this study, the number of participants needed to achieve the study objectives was not determined using statistical assumptions. The proof of concept will be evaluated with the clinical assumption that up to 10 patients maximum will yield the sufficent amount of data required to review any adverse events and device function.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2013
Actual
Date of last participant enrolment
Anticipated
17/10/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 5041 0
New Zealand
State/province [1] 5041 0
Country [2] 5042 0
Turkey
State/province [2] 5042 0

Funding & Sponsors
Funding source category [1] 287160 0
Commercial sector/Industry
Name [1] 287160 0
Ellipse Technologies, Inc.
Country [1] 287160 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Ellipse Technologies, Inc.
Address
13900 Alton Parkway 123
irvine, CA 92618
Country
United States of America
Secondary sponsor category [1] 285928 0
None
Name [1] 285928 0
Address [1] 285928 0
Country [1] 285928 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289157 0
Health and Disability Ethics Committees
Ethics committee address [1] 289157 0
Ethics committee country [1] 289157 0
New Zealand
Date submitted for ethics approval [1] 289157 0
02/05/2013
Approval date [1] 289157 0
Ethics approval number [1] 289157 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39510 0
Mr John Mckie
Address 39510 0
Cashmere Consulting Rooms
91 Cashmere Road
Christchurch 8022
Country 39510 0
New Zealand
Phone 39510 0
+64 03 364 0640
Fax 39510 0
Email 39510 0
jsmckie@xtra.co.nz
Contact person for public queries
Name 39511 0
Rachel March
Address 39511 0
The Princess Margaret Hospital
Cashmere Road
PO Box 731
Christchurch 8022
Country 39511 0
New Zealand
Phone 39511 0
+64 3 3377752
Fax 39511 0
Email 39511 0
rachel.march@gm-research.org.nz
Contact person for scientific queries
Name 39512 0
Chris Hafner
Address 39512 0
Clinical Affairs Manager
Ellipse Technologies, Inc.
13900 Alton Parkway 123
Irvine, CA 92618
Country 39512 0
United States of America
Phone 39512 0
+1 949 837 3600
Fax 39512 0
Email 39512 0
chafner@ellipse-tech.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.