Clinical trial NCT03489876: Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
Official title: Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metatarsophalangeal Joint Arthritis
Keywords: Metatarsophalangeal Joint
Arthritis
Synthetic Cartilage Implant
Cartiva
Osteochondral Autograft Transfer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon eligibility verification and informed consent, computer-based randomization will allot patients into one of the two treatment groups, either synthetic cartilage implant or osteochondral autograft transfer.
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.

Detailed description: First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first MTP joint. Osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first MTP joint and transferring the graft to the head of the first metatarsal. A new synthetic cartilage implant, Cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first MTP range of motion in the Cartiva group was maintained or even improved in some patients.

This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. The hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 80 years old
* Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification
* Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting
* Capable of consenting for self

Exclusion Criteria:

* Patients \<18 years of age
* Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification
* Active bacterial infection of the foot
* Previous bilateral total knee arthroplasty
* Previous fracture or significant trauma to the ipsilateral knee
* Inflammatory anthropathy
* Gout
* Inadequate bone stock
* Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP

Primary outcomes:
measure: Range of Motion
timeFrame: 2 years
measure: Patient's Pain Level
timeFrame: 2 years
Secondary outcomes:
measure: Patient's Quality of Life
timeFrame: 2 years
measure: Clinically-Assessed Foot and Ankle Function
timeFrame: 2 years
measure: Health Status
timeFrame: 2 years
measure: Surgical Complications
timeFrame: 2 years
measure: Implant Failure
timeFrame: 2 years
measure: Secondary Surgical Intervention
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopedic Surgery and Rehabilitation
name: Amgad Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: