Avascular Necrosis of BoneTalarAVNNCT02289976
Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression
A study testing core decompression in people with Avascular Necrosis of Bone, run by BG Trauma Center Ludwigshafen at 1 site in Germany.
Trial summary
The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis of Bone
- What is being tested?
- core decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Nov 2016
- Phase
- Interventional
- 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
- patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)
Who cannot join
- talar avascular necrosis stage I (without need for surgical intervention)
- surgical revascularization in the past
- participation in a different study
- pregnancy
- peripheral artery occlusive disease
- drug associated talar avascular necrosis
- ongoing steroid therapy or chemo therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
BG Trauma Center Ludwigshafen
Ludwigshafen am Rhein, Rhineland-Palatinate, 67071
Victoria F Struckmann, MD, 0049-176-63158299, vfs@me.com
Thomas Kremer, PhD, MD, 0049-621-68108913, thomas.kremer@bgu-ludwigshafen.de
About this study
Official title: Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Autografting
The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.
Read the detailed description
The aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and III). The randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle.
Talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. The extend of this malperfusion is variable and can be categorized in 4 stages. The osseous defects can remain without consequences (stage I) or lead to irreversible talar destruction. The current treatment option for stage II and III is the core decompression followed by osseous auto grafting from the iliac crest. Reducing the intraosseal pressure and filling the drill holes with the nonvascularized bone graft can lead to reperfusion of the talus.
A new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. This procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head.
Patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. Well established scores like the AOFAS Ankle-Hindfoot Score and the Lower Extremity Functional Scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. X-Rays are taken at the same stages. MRIs of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery.
Statistical analysis is performed using the Statistical Package for the Social Sciences (SPSS). The Study protocol has been approved by the Ethics Commission of Rheinland-Pfalz. Interventions are done according to the declaration of Helsinki.
- Conditions
- Avascular Necrosis of Bone
- Being tested
- core decompression
- Keywords
- talar avascular necrosis, osteochondrosis dissecans, femoral condyle
- Medical subject headings
- Osteonecrosis, Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core decompressionProcedure or surgery
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
| Study group | Role | What they receive |
|---|---|---|
| femoral condyle | Active comparator | Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting Receives: Procedure: core decompression |
| core decompression | Active comparator | Core decompression and nonvascularized autograft from the iliac crest Receives: Procedure: core decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
measured by visual anloge scale
Measured: pre operation; 3, 6, 12 months post operation
Secondary outcomes (3)
Revascularization of the talus in the MRI
by ARCO-Criteria
Measured: 6, 12 month post operation
Lower Extremity Functional Scale
Measured: pre operation; 3, 6, 12 month post operation
American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score
Measured: pre operation; 3, 6, 12 month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Avascular Necrosis of BoneStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Ludwigshafen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kremer, Phd, MD, Study director, BG Trauma Center Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289976
- Sponsor's protocol ID
- BGU-01/14
- Acronym
- TalarAVN
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ficat RP. Idiopathic bone necrosis of the femoral head. Early diagnosis and treatment. J Bone Joint Surg Br. 1985 Jan;67(1):3-9. doi: 10.1302/0301-620X.67B1.3155745. No abstract available.
PubMed 3155745BERNDT AL, HARTY M. Transchondral fractures (osteochondritis dissecans) of the talus. J Bone Joint Surg Am. 1959 Sep;41-A:988-1020. No abstract available.
PubMed 13849029Doi K, Sakai K. Vascularized periosteal bone graft from the supracondylar region of the femur. Microsurgery. 1994;15(5):305-15. doi: 10.1002/micr.1920150505.
PubMed 7934797Hussl H, Sailer R, Daniaux H, Pechlaner S. Revascularization of a partially necrotic talus with a vascularized bone graft from the iliac crest. Arch Orthop Trauma Surg. 1989;108(1):27-9. doi: 10.1007/BF00934153.
PubMed 2643938
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Autografting
- ClinicalTrials.gov ID
- NCT02289976
- Acronym / sponsor ID
- TalarAVN / BGU-01/14
- Conditions
- Avascular Necrosis of Bone
- Keywords
- talar avascular necrosis, osteochondrosis dissecans, femoral condyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BG Trauma Center LudwigshafenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 13 Nov 2014 (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 purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.
Detailed description
The aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and III). The randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle.
Talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. The extend of this malperfusion is variable and can be categorized in 4 stages. The osseous defects can remain without consequences (stage I) or lead to irreversible talar destruction. The current treatment option for stage II and III is the core decompression followed by osseous auto grafting from the iliac crest. Reducing the intraosseal pressure and filling the drill holes with the nonvascularized bone graft can lead to reperfusion of the talus.
A new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. This procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head.
Patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. Well established scores like the AOFAS Ankle-Hindfoot Score and the Lower Extremity Functional Scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. X-Rays are taken at the same stages. MRIs of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery.
Statistical analysis is performed using the Statistical Package for the Social Sciences (SPSS). The Study protocol has been approved by the Ethics Commission of Rheinland-Pfalz. Interventions are done according to the declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral condyle | Active comparator | Procedure: core decompressionCore decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting |
| core decompression | Active comparator | Procedure: core decompressionCore decompression and nonvascularized autograft from the iliac crest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)
Key exclusion criteria (7 listed)
- talar avascular necrosis stage I (without need for surgical intervention)
- surgical revascularization in the past
- participation in a different study
- pregnancy
- peripheral artery occlusive disease
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 |
|---|---|---|
| core decompressionDrilling of the avascular necrosis of the talus by 10mm drill under x-ray control | Procedure or surgery | core decompression, femoral condyle |
Primary outcome
Pain reduction
Time frame: pre operation; 3, 6, 12 months post operation
measured by visual anloge scale
3 secondary outcomes
Revascularization of the talus in the MRI
Time frame: 6, 12 month post operation
Lower Extremity Functional Scale
Time frame: pre operation; 3, 6, 12 month post operation
American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score
Time frame: pre operation; 3, 6, 12 month post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 3155745Ficat RP. Idiopathic bone necrosis of the femoral head. Early diagnosis and treatment. J Bone Joint Surg Br. 1985 Jan;67(1):3-9. doi: 10.1302/0301-620X.67B1.3155745. No abstract available.
- Background: PubMed 13849029BERNDT AL, HARTY M. Transchondral fractures (osteochondritis dissecans) of the talus. J Bone Joint Surg Am. 1959 Sep;41-A:988-1020. No abstract available.
- Results publication: PubMed 7934797Doi K, Sakai K. Vascularized periosteal bone graft from the supracondylar region of the femur. Microsurgery. 1994;15(5):305-15. doi: 10.1002/micr.1920150505.
- Results publication: PubMed 2643938Hussl H, Sailer R, Daniaux H, Pechlaner S. Revascularization of a partially necrotic talus with a vascularized bone graft from the iliac crest. Arch Orthop Trauma Surg. 1989;108(1):27-9. doi: 10.1007/BF00934153.
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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 Kremer, Phd, MD study director
BG Trauma Center Ludwigshafen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core decompression in people with Avascular Necrosis of Bone, run by BG Trauma Center Ludwigshafen at 1 site in Germany.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Nov 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 Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria F Struckmann, MD (0049-17663158299, vfs@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: pre operation; 3, 6, 12 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289976, which also lists 4 linked publications.
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 13 Nov 2014.