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

Primary Purpose

Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ascension® MCP Finger Implant
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Shoulder Elbow and Hand Center, P.C.
  • Bloomington Bone and Joint Clinic
  • Reconstructive Hand Surgeons of Indiana
  • The Indiana Hand Center
  • Mayo Clinic Rochester
  • The Center for Ortho/ Neuro Care & Research
  • ROC Houston, PA
  • Fondren Orthopedic Group, L.L.P.
  • The Hand Center of San Antonio

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ascension® MCP Finger Implant

Arm Description

Single arm study, patient treated with Ascension® PyroCarbon MCP implant.

Outcomes

Primary Outcome Measures

Number of Participants With Revisions
Count of participants with a revision surgery.

Secondary Outcome Measures

Change in Joint Range of Motion
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.
Change in Radial-Ulnar Deviation
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.
Change in Tip Pinch
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.
Change in Grip Strength
Implanted hand grip strength measured using a grip dynamometer instrument.
Function Visual Analog Scale (VAS)
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
Joint Pain Visual Analog Score (VAS)
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.
Cosmetic Appearance Visual Analog Scale (VAS)
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.
Joint Position
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.
Component Migration
Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
Bone Changes by Device
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.

Full Information

First Posted
November 4, 2014
Last Updated
October 6, 2023
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02408471
Brief Title
Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Acronym
MCP
Official Title
Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Business Priorities
Study Start Date
June 2002 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ascension® MCP Finger Implant
Arm Type
Other
Arm Description
Single arm study, patient treated with Ascension® PyroCarbon MCP implant.
Intervention Type
Device
Intervention Name(s)
Ascension® MCP Finger Implant
Intervention Description
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.
Primary Outcome Measure Information:
Title
Number of Participants With Revisions
Description
Count of participants with a revision surgery.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Joint Range of Motion
Description
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.
Time Frame
Preoperatively to 12 months
Title
Change in Radial-Ulnar Deviation
Description
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.
Time Frame
Preoperatively to 12 months
Title
Change in Tip Pinch
Description
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.
Time Frame
Preoperatively to 12 months
Title
Change in Grip Strength
Description
Implanted hand grip strength measured using a grip dynamometer instrument.
Time Frame
Preoperatively to 12 months
Title
Function Visual Analog Scale (VAS)
Description
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
Time Frame
Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Title
Joint Pain Visual Analog Score (VAS)
Description
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.
Time Frame
Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
Title
Cosmetic Appearance Visual Analog Scale (VAS)
Description
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.
Time Frame
Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
Title
Joint Position
Description
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.
Time Frame
Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Title
Component Migration
Description
Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
Time Frame
6 Weeks, 12 Weeks, 6 Months, 12 Months
Title
Bone Changes by Device
Description
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.
Time Frame
6 Weeks, 12 Weeks, 6 Months, 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Tummon
Organizational Affiliation
Sponsor- Integra LifeSciences
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Shoulder Elbow and Hand Center, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Bloomington Bone and Joint Clinic
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Reconstructive Hand Surgeons of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
The Indiana Hand Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Center for Ortho/ Neuro Care & Research
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
ROC Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Fondren Orthopedic Group, L.L.P.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Hand Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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