Synthetic Cartilage Implant Versus Interposition Arthroplasty in Hallux Rigidus Treatment: A Randomized Clinical Trial

NCT05518721 | Withdrawn

• 1 other identifier: 202010411
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A minimum of 100 patients with grade III hallux rigidus will be randomized in two parallel groups for surgical care. The first group will be submitted to the insertion of a synthetic cartilage implant at the metatarsophalangeal (MTP) joint. The second group will receive a dermal interposition arthroplasty at the MTP. Both sides will undergo the same post-operative protocol. Pain, complications, and functional results will be evaluated in a minimal of two years of follow-up.

Conditions

Hallux Rigidus

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes

  To compare patient reported outcomes (PROs) of patients undergoing HR treatment using a synthetic implant and utilizing interposition arthroplasty.

  96 weeks post-surgery

Secondary Outcomes (2)

• Survival

  6 months post-surgery

• Complications

  6 months post-surgery

Study Arms (2)

Synthetic Cartilage Implant

ACTIVE COMPARATOR

Procedure: Hallux Rigidus Treatment

Dermal Interposition Arthroplasty

ACTIVE COMPARATOR

Procedure: Hallux Rigidus Treatment

Interventions

Hallux Rigidus Treatment PROCEDURE

Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty

Dermal Interposition Arthroplasty; Synthetic Cartilage Implant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be older than 18 and younger than 75 years of age, both genders.
• Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery.
• Clinical and radiographical clinical diagnosis of hallux rigidus.
• Hallux Rigidus grade III or grade IV.
• Surgical indication after failure of nonoperative treatment (at least six months).

You may not qualify if:

• Previous hallux metatarsophalangeal fusion.
• Less than 20 degrees of complete range of motion on the hallux metatarsophalangeal joint.
• Patient desire or medical indication for a hallux metatarsophalangeal joint arthrodesis.
• Patient desire or medical indication for other surgical modalities.
• History or documented evidence of autoimmune or peripheral vascular diseases.
• History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, seronegative, connective, etc.).
• Any condition that represents a contraindication of the proposed therapies.
• Any physical or social limitation that makes the protocol continuation unviable.
• Impossibility or incapacity to sign the informed Consent Form.
• Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
• Pregnancy.
• Clinical and imaging diagnosis of untreated osteoporosis.
• Serum vitamin D levels below 20ng/ml.
• Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling.
• Tumor lesions (primary or secondary tumors).

Sponsors & Collaborators

• John Femino: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Study Officials

• John Femino, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: July 5, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)