Clinical and functional outcome after cheilectomy and RegJoint™ implantation in hallux rigidus – An alternative to MTP I arthrodesis?

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040194

Enrollment

Registered

2026-05-04

Start date

2026-05-15

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Status post in-house treatment with cheilectomy and RegJoint™ implantation for hallux rigidus M20.2

Interventions

Group 1: Retrospective analysis of all patients with a history of in-house treatment involving cheilectomy and RegJoint™ implantation for hallux rigidus during the period 01/2018–12/2023 with prospect

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Status post in-house treatment with cheilectomy and RegJoint™ implantation for hallux rigidus between 01/2018 and 12/2023 2. Age = 18 years 3. Minimum follow-up period of 12 months

Exclusion criteria

Exclusion criteria: 1. Neuromuscular diseases 2. Ipsilateral and simultaneous arthrodesis proximal to the tarsometatarsal joint line

Design outcomes

Primary

Measure	Time frame
The primary endpoint is implant survival. Non-survival is defined as removal of the RegJoint™ or conversion to MTP I arthrodesis. Status post in-house treatment with cheilectomy and RegJoint™ implantation for hallux rigidus during the period 01/2018–12/2023 Data collection includes: - Recording of sociodemographic data - Clinical examination of both feet - Patient-reported questionnaires (Foot and Ankle Outcome Score [FAOS], EQ-5D-5L, Numeric Pain Scale [NRS] for pain assessment, American Orthopaedic Foot and Ankle Society Score [AOFAS score], University of California Los Angeles Activity Score [UCLA score], European Foot and Ankle Society [EFAS] score) - Extraction of clinical data (complications/adverse events) from electronic medical records and operative reports - Patient-reported information on revisions performed outside the institution and any complications/adverse events - Pedobarography to assess peak plantar pressures and mean plantar pressures (N/cm²) - Radiographs, if applicable	—

Measure

Time frame

The primary endpoint is implant survival. Non-survival is defined as removal of the RegJoint™ or conversion to MTP I arthrodesis. Status post in-house treatment with cheilectomy and RegJoint™ implantation for hallux rigidus during the period 01/2018–12/2023 Data collection includes: - Recording of sociodemographic data - Clinical examination of both feet - Patient-reported questionnaires (Foot and Ankle Outcome Score [FAOS], EQ-5D-5L, Numeric Pain Scale [NRS] for pain assessment, American Orthopaedic Foot and Ankle Society Score [AOFAS score], University of California Los Angeles Activity Score [UCLA score], European Foot and Ankle Society [EFAS] score) - Extraction of clinical data (complications/adverse events) from electronic medical records and operative reports - Patient-reported information on revisions performed outside the institution and any complications/adverse events - Pedobarography to assess peak plantar pressures and mean plantar pressures (N/cm²) - Radiographs, if applicable

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026