Hallux Valgus Clinical Trial
Official title:
Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.
For the treatment of bone fractures metal screws have been used for decades. Removal of
material is the major disadvantage of conventional osteosynthesis and requires a second
intervention, with all the complications and risks for each patient. Moreover, the metal
screw disturbs as foreign material in the bone and irritates the surrounding soft tissue.
In order to overcome the drawbacks of metal screws human bone screw grafts can be used
instead representing a biodegradable osteosynthesis material with ideal material properties.
The bone graft helps to create a solid, bony connection. This connection leads to an
extension, a bone remodeling, bone installation and optimal reparation process in the
affected area.
This observational study is being conducted in order to overcome the lack of systematic
research to objectively confirm the benefits of the product.
In total 50 patients will be enrolled in this study in several centers in Austria This
observational study will use Shark Screw® grafts manufactured by two tissue banks, the
Austrian Tissue Bank surgebright and the German Institute for Cell and Tissue Replacement
(DZIG). The Shark Screw® grafts were approved by the competent Austrian authority (AGES) in
2016.
All patients participating in this observational study, due to a medical indication, undergo
Hallux valgus correction according to the Austin procedure using the bone screws mentioned
above.
A 12 month postoperative observation period is set. Five routine follow-up examinations
including clinical examination and x-ray analysis will be performed. In case the an
additional routine follow-up examination is necessary for clinical reason within 24 month
post-operative, the patient remains in the study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04473196 -
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
|
N/A | |
| Recruiting |
NCT05587569 -
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
|
N/A | |
| Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
| Completed |
NCT02121119 -
Lidocaine Versus Bupivacaine in Ambulatory Continuous Block With Elastomeric Pump
|
Phase 4 | |
| Enrolling by invitation |
NCT00600899 -
Home Infusors for Analgesia After Foot Surgery
|
Phase 4 | |
| Completed |
NCT05579054 -
Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
|
||
| Terminated |
NCT05082012 -
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
|
N/A | |
| Recruiting |
NCT05051709 -
Can Hypermobility of First Ray Affect Surgical Treatment of Hallux Valgus
|
N/A | |
| Recruiting |
NCT04716140 -
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
|
N/A | |
| Active, not recruiting |
NCT04145882 -
Efficacy of Additional Osteotomies to Correct Hallux Valgus
|
N/A | |
| Completed |
NCT04468555 -
Hallux Valgus Manual Therapy Based on Global Postural Reeducation.
|
N/A | |
| Terminated |
NCT03257540 -
Early Weight-Bearing After Lapidus Arthrodesis
|
||
| Completed |
NCT03846687 -
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
|
||
| Completed |
NCT04365712 -
Osteotomy of the 1st Metatarsal for Hallux Valgus Using Pneumatic Oscillating Saw or Piezoelectric Scalpel
|
N/A | |
| Recruiting |
NCT02282956 -
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
|
Phase 4 | |
| Withdrawn |
NCT01555216 -
Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
|
N/A | |
| Completed |
NCT00683137 -
Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
|
Phase 3 | |
| Terminated |
NCT04103814 -
Effect of Topical CBD Cream for Degenerative Hallux Disorders
|
Phase 2/Phase 3 | |
| Completed |
NCT03423498 -
The Toe-spread-out Exercise in Patients With Hallux Valgus and Without the Deformity
|
N/A | |
| Not yet recruiting |
NCT06076655 -
Hallux Valgus Treatment Developed for Children With Cerebral Palsy
|
N/A |