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Retrospective Data Collection of Plantar Stabilization of Fusions of the 1st Tarsal-metatarsal joint with the ORTHOLOC™ 3Di- Plantar Lapidus Plate System T-I-097

Retrospective Data Collection of Plantar Stabilization of Fusions of the 1st Tarsal-metatarsal joint with the ORTHOLOC™ 3Di- Plantar Lapidus Plate System T-I-097 - Retrospektiv Ortholoc Lapidus Data Collection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032427
Enrollment
100
Registered
2023-09-13
Start date
2023-06-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Only retrospective, data collection and analysis of patients whose medial foot instability or misalform of the foot was treated with a Plantar Lapidus Plate System .

Interventions

Group 1: Retrospective Data Collection of Subjects who previously received the ORTHOLOC™ 3Di Plantar Lapidus Plate System in accordance with following legally cleared Indications for Use for plantar s

Sponsors

Stryker
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: A) Subjects who previously received the ORTHOLOC™ 3Di Plantar Lapidus Plate System in accordance with following legally cleared Indications for Use: for plantar stabilization of arthrodeses/fusions of the first tarsal-metatarsal joint (Lapidus procedure). B) The operation was over a year ago. C) All patients thad meet criteria A and B without gaps and have received a Lapidos Prcedure from the „Chirurgische Praxis Walsrode” beginning  2016.02.01.

Exclusion criteria

Exclusion criteria: Patients with Lapidus Procedure using a different stabilization system then the ORTHOLOC™ 3Di Plantar Lapidus Plate System .

Design outcomes

Primary

MeasureTime frame
Primary Endpoint: Performance Efficacy/performance of the System will be determined by bone consolidation in the intended alignment measured by radiographic assessment and the Investigator’s clinical determination of foot function.

Secondary

MeasureTime frame
Information on device-related Adverse Events will be gathered and analyzed by the Investigator.

Countries

Germany

Contacts

Public ContactGerd-Dieter von Koschitzky

Chirurgische Praxis Walsrode

voko@chirurgie-walsrode.de+491772040575

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026