High Tibia OsteotomyPhase 4NCT00206037
Open Wedge High Tibia Osteotomy
A Phase 4 study testing COLLOSS E and TomoFix Plate in people with High Tibia Osteotomy, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 2 countries.
Trial summary
The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Tibia Osteotomy
- What is being tested?
- COLLOSS E and TomoFix Plate
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2005to Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult and active patient
- Varus malalignment of the leg
- Intact lateral joint compartment
- Physiological age-appropriate ROM in hip, knee and ankle of affected leg
Who cannot join
- BMI>35
- Drug or alcohol abuse
- Known equine protein allergy or immunological anormalities
- Immunosuppressive treatment
- Systemic or severe local inflammation or infections
- History of active malignancy or systemic disease
Show all 12Show fewer
- Impossible to obtain informed consent
- Legal incompetence
- Pregnant and nursing women
- Patients before, during or one year after radio- or chemotherapy
- Patients with metal or metal implants near vulnerable structures
- Patients with pacemakers or other implanted devices
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Henriettenstiftung Hannover
Hanover, 30171
BGU Tuebingen
Tübingen, 72076
About this study
Official title: Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.
Read the detailed description
The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.
- Conditions
- High Tibia Osteotomy
- Being tested
- COLLOSS E, TomoFix Plate
- Keywords
- Tibia osteotomy, Bone healing, Bone filler, Equine Protein, COLLOSS E, TomoFix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLLOSS EDevice
TomoFix PlateDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
Measured: 6 weeks
Secondary outcomes (10)
Bone union
Complication rate
Pain asset on the VAS
Deviation planing angle
Immuno reaction on equine proteins
Range of motion
Ligament stability
Time to pain free walking
WOMAC osteoarthritis index
SF36 Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Study completionFeb 2007
Why it stopped: Interim analysis showed significant results, thus study was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Tibia OsteotomyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Ossacur Inc.
- Investigators
- René K Marti, Prof. MD, Principal investigator, Klinik Gut, St. Moritz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206037
- Sponsor's protocol ID
- 03-hto-colloss-05
- Status last verified
- Nov 2007
- First submitted
- 14 Sep 2005
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
- ClinicalTrials.gov ID
- NCT00206037
- Acronym / sponsor ID
- 03-hto-colloss-05
- Conditions
- High Tibia Osteotomy
- Keywords
- Tibia osteotomy, Bone healing, Bone filler, Equine Protein, COLLOSS E, TomoFix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed significant results, thus study was stopped
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Ossacur Inc.
- Study start
- May 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.
Detailed description
The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult and active patient
- Varus malalignment of the leg
- Intact lateral joint compartment
- Physiological age-appropriate ROM in hip, knee and ankle of affected leg
Key exclusion criteria (12 listed)
- BMI>35
- Drug or alcohol abuse
- Known equine protein allergy or immunological anormalities
- Immunosuppressive treatment
- Systemic or severe local inflammation or infections
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 |
|---|---|---|
| COLLOSS E | Device | – |
| TomoFix Plate | Device | – |
Primary outcome
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
Time frame: 6 weeks
10 secondary outcomes
Bone union
Complication rate
Pain asset on the VAS
Deviation planing angle
Immuno reaction on equine proteins
Range of motion
Ligament stability
Time to pain free walking
WOMAC osteoarthritis index
SF36 Index
Results and safety
The study was stopped early (reason given: Interim analysis showed significant results, thus study was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2007.
Related trials for High Tibia Osteotomy
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Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy
Knee Deformity
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HTO and Tranexamic Acid Study
Osteoarthritis, Knee
Recruiting
Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque
Arthritis (Knee), Varus Knee
Not yet recruiting
Kinematic vs Mechanical Alignment in High Tibial Osteotomy
Osteo Arthritis of the Knee, Genu Varum
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.
René K Marti, Prof. MD principal investigator
Klinik Gut, St. Moritz
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COLLOSS E and TomoFix Plate in people with High Tibia Osteotomy, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 2 countries.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed significant results, thus study was stopped). Results are not available in the source record.
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?
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2007.