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Pseudoarthrosis of BoneNCT05049915

Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

A study testing bioglass (S53P4) and RIA and TCP in people with Pseudoarthrosis of Bone, run by Sebastian Findeisen at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pseudoarthrosis of Bone
What is being tested?
bioglass (S53P4) and RIA and TCP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
1 Jun 2018to 31 Dec 2022
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

  • pseudarthrosis of the tibia or femur
  • bone defect < 5 cc
  • surgical treatment with Masquelet technique

Who cannot join

  • age under 18
  • disagreement
  • patients who require amputation of the affected limb

Trial locations and contacts

1 site in 1 country.

Sebastian Findeisen, Dr. med. contact

+4962215634330

sebastian.findeisen@med.uni-heidelberg.de

Patrick Haubruck, Dr. med. contact

patrick.haubruck@med.uni-heidelberg.de

Germany1 site, 1 recruiting

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69118

    Recruiting

Other trials in Germany

About this study

Official title: Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Non-unions of the Tibia and Femur: a Randomized Controlled Non-inferiority Trial

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.

Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery.

Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.

Being tested
bioglass (S53P4), RIA and TCP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bioglass (S53P4)Device

    surgical procedure: Masquelet defect augmentation with bioglass

  • RIA and TCPDevice

    surgical procedure: Masquelet defect augmentation with RIA and TCP

Study groups in NCT05049915
Study groupRoleWhat they receive
Masquelet technique: bioactive glassExperimentalNot described
Receives: Device: bioglass (S53P4)
Masquelet technique: RIA + TCPActive comparatorNot described
Receives: Device: RIA and TCP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of participants with osseus consolidation evaluation via x-ray

    x-ray in 2 planes; union = cortical bridging of at least three out of four cortices

    Measured: 1 year post-operative Masquelet step II

Secondary outcomes (3)

  1. 12-item Short Form Survey (SF-12)

    Quality of life: Physical Score 23.99938(lowest/worst)-56.57706(highest/best), Mental Score 19.06444(lowest/worst)-60.75781 (highest/best)

    Measured: 1 year post-operative Masquelet step II

  2. Perfusion

    Real-time microperfusion assessment using Contrast enhanced ultra-sound (CEUS), contrasting agent: SonoVue. Objective perfusion quantification (using VueBox). Evaluation of characteristic perfusion parameters such as: wash-in rate, wash-in perfusion index

    Measured: 3 months post-operative Masquelet step II

  3. Rate of participants with osseus consolidation evaluation via CT

    union = cortical bridging of at least three out of four cortices

    Measured: 1 year post-operative Masquelet step II

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start1 Jun 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049915
Sponsor's protocol ID
S-472/2017
Status last verified
Sep 2021
First submitted
8 Jun 2021
Last updated
20 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: anonymized/pseudonymized, data that underlies results in a publication

Publications

  • Einhorn TA. The cell and molecular biology of fracture healing. Clin Orthop Relat Res. 1998 Oct;(355 Suppl):S7-21. doi: 10.1097/00003086-199810001-00003.

    PubMed 9917622

  • Schmidmaier G, Moghaddam A. [Long Bone Nonunion]. Z Orthop Unfall. 2015 Dec;153(6):659-74; quiz 675-6. doi: 10.1055/s-0035-1558259. Epub 2015 Dec 15. German.

    PubMed 26670151

  • Hak DJ, Fitzpatrick D, Bishop JA, Marsh JL, Tilp S, Schnettler R, Simpson H, Alt V. Delayed union and nonunions: epidemiology, clinical issues, and financial aspects. Injury. 2014 Jun;45 Suppl 2:S3-7. doi: 10.1016/j.injury.2014.04.002.

    PubMed 24857025

  • Giannoudis PV, Einhorn TA, Marsh D. Fracture healing: the diamond concept. Injury. 2007 Sep;38 Suppl 4:S3-6. doi: 10.1016/s0020-1383(08)70003-2.

    PubMed 18224731

  • Romano CL, Logoluso N, Meani E, Romano D, De Vecchi E, Vassena C, Drago L. A comparative study of the use of bioactive glass S53P4 and antibiotic-loaded calcium-based bone substitutes in the treatment of chronic osteomyelitis: a retrospective comparative study. Bone Joint J. 2014 Jun;96-B(6):845-50. doi: 10.1302/0301-620X.96B6.33014.

    PubMed 24891588

  • Valimaki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. doi: 10.1177/145749690609500204.

    PubMed 16821652

  • Lindfors N, Geurts J, Drago L, Arts JJ, Juutilainen V, Hyvonen P, Suda AJ, Domenico A, Artiaco S, Alizadeh C, Brychcy A, Bialecki J, Romano CL. Antibacterial Bioactive Glass, S53P4, for Chronic Bone Infections - A Multinational Study. Adv Exp Med Biol. 2017;971:81-92. doi: 10.1007/5584_2016_156.

    PubMed 28050878

  • Lindfors NC, Hyvonen P, Nyyssonen M, Kirjavainen M, Kankare J, Gullichsen E, Salo J. Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis. Bone. 2010 Aug;47(2):212-8. doi: 10.1016/j.bone.2010.05.030.

    PubMed 20624692

  • van Gestel NA, Geurts J, Hulsen DJ, van Rietbergen B, Hofmann S, Arts JJ. Clinical Applications of S53P4 Bioactive Glass in Bone Healing and Osteomyelitic Treatment: A Literature Review. Biomed Res Int. 2015;2015:684826. doi: 10.1155/2015/684826. Epub 2015 Oct 4.

    PubMed 26504821

  • Kokubo T, Takadama H. How useful is SBF in predicting in vivo bone bioactivity? Biomaterials. 2006 May;27(15):2907-15. doi: 10.1016/j.biomaterials.2006.01.017. Epub 2006 Jan 31.

    PubMed 16448693

  • Stoor P, Apajalahti S, Kontio R. Regeneration of Cystic Bone Cavities and Bone Defects With Bioactive Glass S53P4 in the Upper and Lower Jaws. J Craniofac Surg. 2017 Jul;28(5):1197-1205. doi: 10.1097/SCS.0000000000003649.

    PubMed 28538076

  • Stoor P, Pulkkinen J, Grenman R. Bioactive glass S53P4 in the filling of cavities in the mastoid cell area in surgery for chronic otitis media. Ann Otol Rhinol Laryngol. 2010 Jun;119(6):377-82. doi: 10.1177/000348941011900603.

    PubMed 20583735

  • Kankare J, Lindfors NC. Reconstruction of Vertebral Bone Defects using an Expandable Replacement Device and Bioactive Glass S53P4 in the Treatment of Vertebral Osteomyelitis: Three Patients and Three Pathogens. Scand J Surg. 2016 Dec;105(4):248-253. doi: 10.1177/1457496915626834. Epub 2016 Jun 23.

    PubMed 26929284

  • Fischer C, Frank M, Kunz P, Tanner M, Weber MA, Moghaddam A, Schmidmaier G, Hug A. Dynamic contrast-enhanced ultrasound (CEUS) after open and minimally invasive locked plating of proximal humerus fractures. Injury. 2016 Aug;47(8):1725-31. doi: 10.1016/j.injury.2016.05.005. Epub 2016 May 14.

    PubMed 27242329

  • Fischer C, Preuss EM, Tanner M, Bruckner T, Krix M, Amarteifio E, Miska M, Moghaddam-Alvandi A, Schmidmaier G, Weber MA. Dynamic Contrast-Enhanced Sonography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Preoperative Diagnosis of Infected Nonunions. J Ultrasound Med. 2016 May;35(5):933-42. doi: 10.7863/ultra.15.06107. Epub 2016 Apr 1.

    PubMed 27036169

Questions about this trial

What is this clinical trial studying?

A study testing bioglass (S53P4) and RIA and TCP in people with Pseudoarthrosis of Bone, run by Sebastian Findeisen 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 3 inclusion and 3 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 20 Sep 2021. 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 Sebastian Findeisen, Dr. med. (+4962215634330, sebastian.findeisen@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of participants with osseus consolidation evaluation via x-ray (time frame: 1 year post-operative Masquelet step II). 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 NCT05049915, which also lists 19 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 20 Sep 2021.

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