Clinical trial NCT02408471: Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Official title: Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Systemic Lupus Erythematosus
Osteoarthritis
Post-traumatic Arthritis
Keywords: Arthritis
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Osteoarthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.


Eligibility criteria: Inclusion Criteria:

* Indications consistent with the FDA approved Indications For Use: Index, long, ring, or small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization
* Willing to participate in the study
* Signed an Informed Consent Form
* The means and ability to return for all required study visits
* Are not transient

Exclusion Criteria:

Patients who have any of the following contraindications will be excluded from the study:

* Inadequate bone stock at the implantation site
* Active infection in the MCP joint
* Nonfunctioning and irreparable MCP musculotendinous system
* Physical interference with or by other prostheses during implantation or use
* Procedures requiring modification of the prosthesis
* Skin, bone, circulatory and/or neurological deficiency at the implantation site

Primary outcomes:
measure: Number of Participants With Revisions
timeFrame: 12 months
Secondary outcomes:
measure: Change in Joint Range of Motion
timeFrame: Preoperatively to 12 months
measure: Change in Radial-Ulnar Deviation
timeFrame: Preoperatively to 12 months
measure: Change in Tip Pinch
timeFrame: Preoperatively to 12 months
measure: Change in Grip Strength
timeFrame: Preoperatively to 12 months
measure: Function Visual Analog Scale (VAS)
timeFrame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
measure: Joint Pain Visual Analog Score (VAS)
timeFrame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
measure: Cosmetic Appearance Visual Analog Scale (VAS)
timeFrame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
measure: Joint Position
timeFrame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
measure: Component Migration
timeFrame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
measure: Bone Changes by Device
timeFrame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southwest Shoulder Elbow and Hand Center, P.C.
state: Arizona
city: Bloomington
country: United States
facility: Bloomington Bone and Joint Clinic
state: Indiana
city: Carmel
country: United States
facility: Reconstructive Hand Surgeons of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Hand Center
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Bend
country: United States
facility: The Center for Ortho/ Neuro Care & Research
state: Oregon
city: Houston
country: United States
facility: ROC Houston, PA
state: Texas
city: Houston
country: United States
facility: Fondren Orthopedic Group, L.L.P.
state: Texas
city: San Antonio
country: United States
facility: The Hand Center of San Antonio
state: Texas
Study officials:
affiliation: Sponsor- Integra LifeSciences
name: Andrew Tummon
role: STUDY_DIRECTOR
References: