Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus

NCT05602844 | Unknown

• 1 other identifier: HV PSI Lapidus
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.

Conditions

Hallux Valgus; Bunion; Patient Spe

Outcome Measures

Primary Outcomes (10)

• Foot Function

  The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.

  0 week

• Foot Function

  The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.

  12 week

• Foot Function

  The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.

  26 week

• Foot Function

  The Foot and Ankle Outcome Score (FAOS) is a reliable and validated patient-reported questionnaire widely used in clinical settings. It consists of five subscales: pain, symptoms, activities of daily living, ability to perform sports and recreational activities, and quality of life. The score of each part is re-coded into a 0-100 scale, with 100 representing no symptoms. (16) The FAOS is a commonly used outcome assessment tool in hallux valgus trials and is reliable and valid by many researchers.

  52 week

• Time to Radiological Fusion

  Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.

  2 week

• Time to Radiological Fusion

  Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.

  6 week

• Time to Radiological Fusion

  Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.

  12 week

• Time to Radiological Fusion

  Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.

  26 week

• Time to Radiological Fusion

  Dorsal-plantar and lateral X-rays of the foot will be taken to look for evidence of trabeculations crossing the fusion site. A successful union will be declared if trabeculation extends more than one-half the length of the fusion site.

  52 week

• High-resolution peripheral quantitive-Computed Tomography

  HR pQCT allows us to visualize the bony micro-architecture at the Lapidus fusion site and is a more accurate assessment of bone growth compared to X-rays. A rectangular region of interest (ROI) will be established at the fusion surface, inner callus, and external callus area. The volumetric changes in bone mineral density (BMD) in each region will be analyzed.

  6 week

Secondary Outcomes (9)

• Deformity severity

  0 week

• Deformity severity

  12 week

• Deformity severity

  26 week

• Deformity severity

  52 week

• Delayed union rate

  12 week

Study Arms (2)

PSI Lapidus

EXPERIMENTAL

Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery.

Procedure: PSI Lapidus

Conventional Lapidus

ACTIVE COMPARATOR

Lapidus Surgery: exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws.

Procedure: Conventional Lapidus

Interventions

PSI Lapidus PROCEDURE

Design of PSI: DICOM files will be imported into the Model Intestinal Microflora in Computer Simulation (MIMICS 21.0) 3D image processing software (Materialize, Belgium) for 3D rendering. The segmented bone images will be used for design of the computer-aided modelling (CAM) surgical jigs. 3D printing of PSI jig. PSI-assisted Lapidus Surgery.

PSI Lapidus

Conventional Lapidus PROCEDURE

exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws

Conventional Lapidus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Hallux Valgus
• hallux valgus angle \>20
• ,2 Inter-metatarsal angle \>9

You may not qualify if:

• Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

CUHK

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Officials

• Samuel Ling

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by orthopaedic surgeons from the Foot and Ankle team; the patient and the outcome assessor will be blinded while the surgeon will not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: single-blinded, parallel-group, randomised controlled trial will be conducted to compare the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for Surgical Correction of HV Deformity

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)