Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
Arthritis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
Brief summary
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
Interventions
DEVICEAscension® MCP Finger Implant
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Revisions | 12 months | Count of participants with a revision surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radial-Ulnar Deviation | 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. |
| Change in Tip Pinch | 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. |
| Change in Grip Strength | Preoperatively to 12 months | Implanted hand grip strength measured using a grip dynamometer instrument. |
| Function Visual Analog Scale (VAS) | 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 |
| Change in Joint Range of Motion | 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. |
| Cosmetic Appearance Visual Analog Scale (VAS) | 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. |
| Joint Position | 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. |
| Component Migration | 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. |
| Bone Changes by Device | 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. |
| Joint Pain Visual Analog Score (VAS) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from 25 June 2002 to early termination on 03 January 2015.
Pre-assignment details
One bilateral participant completed the study in 2010 for the left hand and the same participant enrolled in the study again in 2011 for the right hand. Each enrollment is accounted for separately as appropriate for the total number of participants enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Ascension® MCP Finger Implant Single arm study, patient treated with Ascension® PyroCarbon MCP implant.
Ascension® MCP Finger Implant: Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP. | 97 |
| Ascension® MCP Finger Implant Single arm study, patient treated with Ascension® PyroCarbon MCP implant.
Ascension® MCP Finger Implant: Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP. | 97 |
| Total | 194 |
Baseline characteristics
| Characteristic | Ascension® MCP Finger Implant |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 12 |
| Number of Affected Joints | 162 joints |
| Race/Ethnicity, Customized Race/Ethnicity Black | 1 hands |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian/White | 42 hands |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 1 hands |
| Race/Ethnicity, Customized Race/Ethnicity Not Retrieved | 47 hands |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 6 hands |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 48 hands |
| Sex: Female, Male Male | 49 hands |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 97 |
| other Total, other adverse events | 30 / 97 |
| serious Total, serious adverse events | 25 / 97 |
Outcome results
Primary
Number of Participants With Revisions
Count of participants with a revision surgery.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ascension® MCP Finger Implant | Number of Participants With Revisions | 6 Participants |
Secondary
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.
Time frame: 6 Weeks, 12 Weeks, 6 Months, 12 Months
Population: Number analyzed for each specified time frame and category includes participants with available finger data.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Weeks | Any Bone Changes | 3 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Weeks | Missing | 1 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Months | None | 103 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Months | Any Bone Changes | 28 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Months | Missing | 0 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Weeks | None | 154 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Weeks | Any Bone Changes | 1 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 6 Weeks | Missing | 0 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Weeks | None | 148 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Months | None | 68 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Months | Any Bone Changes | 52 devices |
| Ascension® MCP Finger Implant | Bone Changes by Device | 12 Months | Missing | 3 devices |
Secondary
Change in Grip Strength
Implanted hand grip strength measured using a grip dynamometer instrument.
Time frame: Preoperatively to 12 months
Population: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ascension® MCP Finger Implant | Change in Grip Strength | -0.8 kilograms | Standard Deviation 14.8 |
Secondary
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.
Time frame: Preoperatively to 12 months
Population: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Change in Joint Range of Motion | Joint Flexion | -6.2 degrees | Standard Deviation 25.8 |
| Ascension® MCP Finger Implant | Change in Joint Range of Motion | Joint Extension | 18.2 degrees | Standard Deviation 30.2 |
Secondary
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.
Time frame: Preoperatively to 12 months
Population: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Change in Radial-Ulnar Deviation | Radial Deviation | 0 degrees | — |
| Ascension® MCP Finger Implant | Change in Radial-Ulnar Deviation | Ulnar Deviation | -9.4 degrees | Standard Deviation 21.1 |
Secondary
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.
Time frame: Preoperatively to 12 months
Population: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ascension® MCP Finger Implant | Change in Tip Pinch | 1.3 kilograms | Standard Deviation 1.9 |
Secondary
Component Migration
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
Population: Number analyzed for each specified time frame and category includes participants with available implanted device data.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Component Migration | 6 Weeks | None | 155 devices |
| Ascension® MCP Finger Implant | Component Migration | 6 Weeks | Yes | 0 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Weeks | Missing | 1 devices |
| Ascension® MCP Finger Implant | Component Migration | 6 Months | None | 130 devices |
| Ascension® MCP Finger Implant | Component Migration | 6 Months | Yes | 1 devices |
| Ascension® MCP Finger Implant | Component Migration | 6 Months | Missing | 0 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Months | None | 123 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Months | Yes | 0 devices |
| Ascension® MCP Finger Implant | Component Migration | 6 Weeks | Missing | 0 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Weeks | None | 151 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Weeks | Yes | 0 devices |
| Ascension® MCP Finger Implant | Component Migration | 12 Months | Missing | 0 devices |
Secondary
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.
Time frame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months
Population: Participants with available data necessary for the assessment specified for the given time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Cosmetic Appearance Visual Analog Scale (VAS) | Preoperatively | 39.8 score on a scale | Standard Deviation 33.8 |
| Ascension® MCP Finger Implant | Cosmetic Appearance Visual Analog Scale (VAS) | 6 Weeks | 71.1 score on a scale | Standard Deviation 23.8 |
| Ascension® MCP Finger Implant | Cosmetic Appearance Visual Analog Scale (VAS) | 12 Weeks | 75.4 score on a scale | Standard Deviation 25.4 |
| Ascension® MCP Finger Implant | Cosmetic Appearance Visual Analog Scale (VAS) | 6 Months | 78.1 score on a scale | Standard Deviation 25.5 |
| Ascension® MCP Finger Implant | Cosmetic Appearance Visual Analog Scale (VAS) | 12 Months | 83.0 score on a scale | Standard Deviation 25.6 |
Secondary
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
Time frame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Population: Participants with available data necessary for the assessment specified for the given time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Function Visual Analog Scale (VAS) | Preoperatively | 29.7 score on a scale | Standard Deviation 20.6 |
| Ascension® MCP Finger Implant | Function Visual Analog Scale (VAS) | 6 Weeks | 52.7 score on a scale | Standard Deviation 25.9 |
| Ascension® MCP Finger Implant | Function Visual Analog Scale (VAS) | 12 Weeks | 70.9 score on a scale | Standard Deviation 25.2 |
| Ascension® MCP Finger Implant | Function Visual Analog Scale (VAS) | 6 Months | 75.2 score on a scale | Standard Deviation 25.7 |
| Ascension® MCP Finger Implant | Function Visual Analog Scale (VAS) | 12 Months | 83.2 score on a scale | Standard Deviation 17.7 |
Secondary
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.
Time frame: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months
Population: Participants with available data necessary for the assessment specified for the given time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Joint Pain Visual Analog Score (VAS) | 12 Weeks | 11.3 score on a scale | Standard Deviation 18.8 |
| Ascension® MCP Finger Implant | Joint Pain Visual Analog Score (VAS) | 6 Months | 10.5 score on a scale | Standard Deviation 20.5 |
| Ascension® MCP Finger Implant | Joint Pain Visual Analog Score (VAS) | 12 Months | 11.8 score on a scale | Standard Deviation 19.4 |
| Ascension® MCP Finger Implant | Joint Pain Visual Analog Score (VAS) | Preoperatively | 65.3 score on a scale | Standard Deviation 28.4 |
| Ascension® MCP Finger Implant | Joint Pain Visual Analog Score (VAS) | 6 Weeks | 16.0 score on a scale | Standard Deviation 20 |
Secondary
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.
Time frame: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Population: Number analyzed for each specified time frame and category includes participants with available finger data.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Joint Position | Preoperatively | Reduced | 78 fingers |
| Ascension® MCP Finger Implant | Joint Position | Preoperatively | Subluxed | 62 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Weeks | Missing | 1 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Months | Subluxed | 2 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Months | Missing | 2 fingers |
| Ascension® MCP Finger Implant | Joint Position | Preoperatively | Dislocated | 20 fingers |
| Ascension® MCP Finger Implant | Joint Position | Preoperatively | Missing | 1 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Weeks | Reduced | 152 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Weeks | Subluxed | 0 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Weeks | Dislocated | 2 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Weeks | Reduced | 148 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Weeks | Subluxed | 2 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Weeks | Dislocated | 0 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Weeks | Missing | 2 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Months | Reduced | 122 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Months | Dislocated | 1 fingers |
| Ascension® MCP Finger Implant | Joint Position | 6 Months | Missing | 6 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Months | Reduced | 118 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Months | Subluxed | 3 fingers |
| Ascension® MCP Finger Implant | Joint Position | 12 Months | Dislocated | 0 fingers |