Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis (MCP)

October 6, 2023 updated by: Smith & Nephew, Inc.

Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Southwest Shoulder Elbow and Hand Center, P.C.
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Bloomington Bone and Joint Clinic
      • Carmel, Indiana, United States, 46032
        • Reconstructive Hand Surgeons of Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Indiana Hand Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Oregon
      • Bend, Oregon, United States, 97701
        • The Center for Ortho/ Neuro Care & Research
    • Texas
      • Houston, Texas, United States, 77004
        • ROC Houston, PA
      • Houston, Texas, United States, 77030
        • Fondren Orthopedic Group, L.L.P.
      • San Antonio, Texas, United States, 78229
        • The Hand Center of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ascension® MCP Finger Implant
Single arm study, patient treated with Ascension® PyroCarbon MCP implant.
Device: Ascension® MCP Finger Implant
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Revisions
Time Frame: 12 months
Count of participants with a revision surgery.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Joint Range of Motion
Time Frame: Preoperatively to 12 months
Range of motion measured by clinical assessment for joint extension and joint flexion. Measurements of extension and flexion made and recorded to the nearest degree using a goniometer with the wrist in the neutral position. Extension measured with fingers actively extended and flexion measured after the participant made a fist.
Preoperatively to 12 months
Change in Radial-Ulnar Deviation
Time Frame: Preoperatively to 12 months
Measurements of ulnar deviation made for each implanted metacarpophalangeal (MCP) joint. Measurements made to the nearest degree using a goniometer with the participant's wrist in a neutral position and the finger(s) fully extended (e.g., no extension deficit). Radial deviation or ulnar deviation direction checked.
Preoperatively to 12 months
Change in Tip Pinch
Time Frame: Preoperatively to 12 months

Quantitative measurements of opposition tip pinch strength was made for each implanted digit. Measurements made using a pinch meter.

For each strength measurement, the participant made 3 attempts with the maximum value recorded.

If the participant could not perform the pinch test due to inflammation, excessive pain, or some other reason, DNA (which stands for "Did Not Attempt") was recorded. If the participant performs the pinch test but cannot register significant load, the value zero (0) was recorded.
Preoperatively to 12 months
Change in Grip Strength
Time Frame: Preoperatively to 12 months
Implanted hand grip strength measured using a grip dynamometer instrument.
Preoperatively to 12 months
Function Visual Analog Scale (VAS)
Time Frame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
VAS Function based on a scale of 0 to 100 as completed by the participant with 0 indicating worse function and 100 indicating normal function
Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Joint Pain Visual Analog Score (VAS)
Time Frame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
VAS Joint Pain based on a scale of 0 to 100 as completed by the participant with 0 indicating no pain and 100 indicating severe pain.
Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
Cosmetic Appearance Visual Analog Scale (VAS)
Time Frame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
VAS Cosmetic Appearance based on a scale of 0 to 100 as completed by the participant with 0 indicating worst appearance and 100 indicating normal appearance.
Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
Joint Position
Time Frame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Joint position for the affected finger determined by radiographic evaluation. Standard anteroposterior (AP), oblique, and lateral radiographs were made at the pre-operative and all post-operative evaluation visits of the hand(s) in which the Ascension MCP device was implanted. Joint position was classified as reduced, subluxed, dislocated, or (data) missing.
Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Component Migration
Time Frame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
6 Weeks, 12 Weeks, 6 Months, 12 Months
Bone Changes by Device
Time Frame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
X-rays were examined to determine if the implant components demonstrate stable fixation in the bone. Bone changes were classified as no changes (i.e., none), any bone changes, or (data) missing.
6 Weeks, 12 Weeks, 6 Months, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Study Director: Andrew Tummon, Sponsor- Integra LifeSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2002

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimated)

April 3, 2015

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-MCP-002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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