Osteoarthritis, KneePhase 4NCT00319280
Proximal Tibial Open Wedge Osteotomy. A Clinical Prospective, Randomized RSA-trial.
A Phase 4 study of Osteoarthritis, Knee, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient. However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2004to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- Candidate for proximal tibial medial open-wedge osteotomy
- Signed informed consent
Who cannot join
- Prednisolone treatment.
- NSAID treatment.
- BMI > or = 35.
- Previous surgery in lateral knee compartment.
- Secondary Arthrosis following fracture(s) of the tibial condyle(s).
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
Farsø, Northern Jutland
About this study
Official title: Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Read more
Hitherto the golden standard has been autograft taken from iliac crest but there are donorsite related problems and limited amount available.
Recently injectable and resorbable calciumphosphate-cements have been introduced and used with promising results in fractures of the distal radius, calcaneus and lateral tibial condyle.
These new cements seem to be a good alternative to other bone substitutes providing high initial strength that might promote early mobilisation; it resorbs and promotes osteoconduction securing safe healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies with three different bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement Calcibon and as control a group with an empty gap.
Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as a randomised prospective clinical trial including 45 patients with a planned 2 years follow-up period.
Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.
Routine standing x-rays is performed. Stability is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.
This combined with urine and serum bone-healing markers gives a very precise picture of the healing in the bone-gap.
To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen type II degradation are measured.
- Conditions
- Osteoarthritis, Knee
- Being tested
- bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)
- Keywords
- Osteoarthritis, Knee, Osteotomy, Healing, Roentgen Stereometric Analysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)Procedure or surgery
Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Minced Iliac Crest autograft in osteotomysite Receives: Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control) |
| 2 | Experimental | Injectable calcium phosphate cement in osteotomysite Receives: Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control) |
| 3 | Active comparator | Local autograft in the osteotomysite serves as control Receives: Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration in mm measured with RSA (Roentgen Stereometric Analysis)
Measured: postoperative, at 3 month, 1 and 2 years
Secondary outcomes (6)
Hip-Knee-Ankle axis
Measured: 3 month, 1 and 2 years.
MR of the knee
Measured: 4 weeks preoperative, preoperative, at 1 and 2 years postoperative.
Markers of chondral degradation
Measured: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
Markers of bone synthesis and degradation
Measured: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
Clinical scores: KOOS, Lysholm, SF12, Knee Score
Measured: Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years
Histomorphometric evaluation of bone healing and osseous integration of cement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startDec 2004
- Primary completionJun 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Company CCBR A/S
- Responsible party
- Sponsor
- Investigators
- Thomas Lind-Hansen, MD, Principal investigator, Northern Orthopaedic Division, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319280
- Sponsor's protocol ID
- ON-01-004-ML
- Status last verified
- Mar 2014
- First submitted
- 27 Apr 2006
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Tibial Open Wedge Osteotomy. Stability and Healing Evaluated in a Clinical Prospective, Randomized Trial Using RSA.
- ClinicalTrials.gov ID
- NCT00319280
- Acronym / sponsor ID
- ON-01-004-ML
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Osteotomy, Healing, Roentgen Stereometric Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Company CCBR A/S
- Study start
- Dec 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Apr 2006 (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.
In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.
However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.
Hitherto the golden standard has been autograft taken from iliac crest but there are donorsite related problems and limited amount available.
Recently injectable and resorbable calciumphosphate-cements have been introduced and used with promising results in fractures of the distal radius, calcaneus and lateral tibial condyle.
These new cements seem to be a good alternative to other bone substitutes providing high initial strength that might promote early mobilisation; it resorbs and promotes osteoconduction securing safe healing.
The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies with three different bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement Calcibon and as control a group with an empty gap.
Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as a randomised prospective clinical trial including 45 patients with a planned 2 years follow-up period.
Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.
Routine standing x-rays is performed. Stability is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.
This combined with urine and serum bone-healing markers gives a very precise picture of the healing in the bone-gap.
To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen type II degradation are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)Minced Iliac Crest autograft in osteotomysite |
| 2 | Experimental | Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)Injectable calcium phosphate cement in osteotomysite |
| 3 | Active comparator | Procedure: bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)Local autograft in the osteotomysite serves as control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- Candidate for proximal tibial medial open-wedge osteotomy
- Signed informed consent
Key exclusion criteria (6 listed)
- Prednisolone treatment.
- NSAID treatment.
- BMI > or = 35.
- Previous surgery in lateral knee compartment.
- Secondary Arthrosis following fracture(s) of the tibial condyle(s).
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 |
|---|---|---|
| bonesubstitution (Calcibon, Iliac Crest Bonegraft, control)Osteotomysite are filled with Calcibon (an injectable calcium phosphate cement) or Minced Iliac Crest Bonegraft og local graft as control | Procedure or surgery | 1, 2, 3 |
Primary outcome
Migration in mm measured with RSA (Roentgen Stereometric Analysis)
Time frame: postoperative, at 3 month, 1 and 2 years
6 secondary outcomes
Hip-Knee-Ankle axis
Time frame: 3 month, 1 and 2 years.
MR of the knee
Time frame: 4 weeks preoperative, preoperative, at 1 and 2 years postoperative.
Markers of chondral degradation
Time frame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
Markers of bone synthesis and degradation
Time frame: preoperative, at 6 weeks, 3 month, 1 and 2 years postoperative
Clinical scores: KOOS, Lysholm, SF12, Knee Score
Time frame: Preoperatively, Postoperatively, 6 weeks, 3 months, 1 year and 2 years
Histomorphometric evaluation of bone healing and osseous integration of cement
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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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.
Thomas Lind-Hansen, MD principal investigator
Northern Orthopaedic Division, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Osteoarthritis, Knee, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 3 inclusion and 6 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 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Migration in mm measured with RSA (Roentgen Stereometric Analysis) (time frame: postoperative, at 3 month, 1 and 2 years). 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 31 Mar 2014.