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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hallux Rigidus
• Intervention / Treatment: Procedure: Hallux Rigidus Treatment

Detailed Description

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.

The synthetic implant begins by performing and dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally, osteophytes removed, and a guidewire inserted through the center of the first metatarsal head. The position of the metallic wire is checked and the tunnel for the implant is drilled. The synthetic cartilage implant (Cartiva™, Stryker Medical®) is introduced through the tunnel, leaving it proud with the head surface by 2mm. The capsule is closed, followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.

The interposition arthroplasty initiates with the same dorsal midline approach, from the proximal phalanx diaphysis to the first metatarsal neck. Dissection is carried avoiding injury to the dorsal cutaneous nerves and the extensor hallucis longus tendon. The capsule is open longitudinally and osteophytes are removed. A guidewire inserted through the center of the first metatarsal head and the center of the proximal phalanx for proper surface preparation. Convex-concaves anatomical drills are used, removing remaining cartilage and opening space for the graft. A decellularized dermal allograft (Arthroflex™, Arthrex®) is placed at the joint and sutured to the head, maintaining the epidermal surface in contact with the phalanx. The graft is trimmed, the capsule is closed, which is followed by the other planes and the skin. The patient is banded and placed in a postoperative hard sole shoe for six weeks. Range of motion is encouraged from the third week and the shoe is discontinued after the sixth week. Return to sports activities and normal shoewear occurs by twelve weeks.

The WBCT is the standard of care for the preoperative and postoperative assessment of patients with hallux rigidus. Some of the complications will also be evaluated through WBCT. No extra WBCT will be performed other than what we normally do for patients.

Randomization will be performed previously at the beginning of the study and will be performed by an outside researcher. Allocation will happen during surgery scheduling.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar De Cesar Netto, MD; Phone Number: (319) 678-7943; Email: cesar-netto@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Synthetic Cartilage Implant	Procedure: Hallux Rigidus Treatment; Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty
Active Comparator: Dermal Interposition Arthroplasty	Procedure: Hallux Rigidus Treatment; Participants will receive either a synthetic cartilage implant or dermal interposition arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	To compare survival rate (reoperation) between the two techniques.	6 months post-surgery
Complications	To compare major and minor complications between the two groups	6 months post-surgery

Collaborators and Investigators

• Sponsor: John Femino
• Investigators: Principal Investigator: John Femino, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2022
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: 202010411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No