Rheumatoid ArthritisMCPNCT02408471
Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
A study testing Ascension® MCP Finger Implant in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Smith & Nephew, Inc. at 9 sites in United States.
Trial summary
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis
- What is being tested?
- Ascension® MCP Finger Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2002to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Center for Ortho/ Neuro Care & Research
Bend, Oregon, 97701
Bloomington Bone and Joint Clinic
Bloomington, Indiana, 47403
Reconstructive Hand Surgeons of Indiana
Carmel, Indiana, 46032
ROC Houston, PA
Houston, Texas, 77004
Fondren Orthopedic Group, L.L.P.
Houston, Texas, 77030
The Indiana Hand Center
Indianapolis, Indiana, 46260
Mayo Clinic Rochester
Rochester, Minnesota, 55905
The Hand Center of San Antonio
San Antonio, Texas, 78229
Southwest Shoulder Elbow and Hand Center, P.C.
Tucson, Arizona, 85712
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis
- Being tested
- Ascension® MCP Finger Implant
- Keywords
- Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Osteoarthritis, Arthritis, Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascension® MCP Finger ImplantDevice
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.
| Study group | Role | What they receive |
|---|---|---|
| Ascension® MCP Finger Implant | Other | Single arm study, patient treated with Ascension® PyroCarbon MCP implant. Receives: Device: Ascension® MCP Finger Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Revisions
Count of participants with a revision surgery.
Measured: 12 months
Secondary outcomes (10)
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.
Measured: Preoperatively to 12 months
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.
Measured: Preoperatively to 12 months
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.
Measured: Preoperatively to 12 months
Change in Grip Strength
Implanted hand grip strength measured using a grip dynamometer instrument.
Measured: Preoperatively to 12 months
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
Measured: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
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.
Measured: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
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.
Measured: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
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.
Measured: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Component Migration
Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
Measured: 6 Weeks, 12 Weeks, 6 Months, 12 Months
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.
Measured: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJun 2002
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Business Priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tummon, Study director, Sponsor- Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408471
- Sponsor's protocol ID
- CP-MCP-002
- Acronym
- MCP
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2014
- Last updated
- 10 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
- ClinicalTrials.gov ID
- NCT02408471
- Acronym / sponsor ID
- MCP / CP-MCP-002
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Priorities
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2002 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascension® MCP Finger Implant | Other | Device: Ascension® MCP Finger ImplantSingle arm study, patient treated with Ascension® PyroCarbon MCP implant. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascension® MCP Finger ImplantPatients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP. | Device | Ascension® MCP Finger Implant |
Primary outcome
Number of Participants With Revisions
Time frame: 12 months
Count of participants with a revision surgery.
10 secondary outcomes
Change in Joint Range of Motion
Time frame: Preoperatively to 12 months
Change in Radial-Ulnar Deviation
Time frame: Preoperatively to 12 months
Change in Tip Pinch
Time frame: Preoperatively to 12 months
Change in Grip Strength
Time frame: Preoperatively to 12 months
Function Visual Analog Scale (VAS)
Time frame: 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
Cosmetic Appearance Visual Analog Scale (VAS)
Time frame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
Joint Position
Time frame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Component Migration
Time frame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Bone Changes by Device
Time frame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Tummon study director
Sponsor- Integra LifeSciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascension® MCP Finger Implant in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Smith & Nephew, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Revisions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.