Trial Outcomes & Findings for Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis (NCT NCT02408471)
NCT ID: NCT02408471
Last Updated: 2023-10-10
Results Overview
Count of participants with a revision surgery.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
12 months
Results posted on
2023-10-10
Participant Flow
Participants recruited from 25 June 2002 to early termination on 03 January 2015.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only data available for age used for analysis.
Baseline characteristics by cohort
| Measure |
Ascension® MCP Finger Implant
n=97 hands
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.
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.0 • n=92 Participants • Only data available for age used for analysis.
|
|
Sex: Female, Male
Female
|
48 hands
n=97 hands
|
|
Sex: Female, Male
Male
|
49 hands
n=97 hands
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
1 hands
n=97 hands
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian/White
|
42 hands
n=97 hands
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino
|
1 hands
n=97 hands
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
6 hands
n=97 hands
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Retrieved
|
47 hands
n=97 hands
|
|
Region of Enrollment
United States
|
97 participants
n=97 Participants
|
|
Number of Affected Joints
|
162 joints
n=97 Participants
|
PRIMARY outcome
Timeframe: 12 monthsCount of participants with a revision surgery.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=97 Participants
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.
|
|---|---|
|
Number of Participants With Revisions
|
6 Participants
|
SECONDARY outcome
Timeframe: Preoperatively to 12 monthsPopulation: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=122 joints
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.
|
|---|---|
|
Change in Joint Range of Motion
Joint Extension
|
18.2 degrees
Standard Deviation 30.2
|
|
Change in Joint Range of Motion
Joint Flexion
|
-6.2 degrees
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: Preoperatively to 12 monthsPopulation: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=102 joints
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.
|
|---|---|
|
Change in Radial-Ulnar Deviation
Radial Deviation
|
0 degrees
Standard Deviation NA
Standard Deviation could not be calculated due to insufficient participant data available for Radial Deviation.
|
|
Change in Radial-Ulnar Deviation
Ulnar Deviation
|
-9.4 degrees
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Preoperatively to 12 monthsPopulation: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=113 joints
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.
|
|---|---|
|
Change in Tip Pinch
|
1.3 kilograms
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Preoperatively to 12 monthsPopulation: Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified.
Implanted hand grip strength measured using a grip dynamometer instrument.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=108 joints
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.
|
|---|---|
|
Change in Grip Strength
|
-0.8 kilograms
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 monthsPopulation: Participants with available data necessary for the assessment specified for the given time frame.
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
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=97 Participants
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.
|
|---|---|
|
Function Visual Analog Scale (VAS)
Preoperatively
|
29.7 score on a scale
Standard Deviation 20.6
|
|
Function Visual Analog Scale (VAS)
6 Weeks
|
52.7 score on a scale
Standard Deviation 25.9
|
|
Function Visual Analog Scale (VAS)
12 Weeks
|
70.9 score on a scale
Standard Deviation 25.2
|
|
Function Visual Analog Scale (VAS)
6 Months
|
75.2 score on a scale
Standard Deviation 25.7
|
|
Function Visual Analog Scale (VAS)
12 Months
|
83.2 score on a scale
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 MonthsPopulation: Participants with available data necessary for the assessment specified for the given time frame.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=97 Participants
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.
|
|---|---|
|
Joint Pain Visual Analog Score (VAS)
Preoperatively
|
65.3 score on a scale
Standard Deviation 28.4
|
|
Joint Pain Visual Analog Score (VAS)
6 Weeks
|
16.0 score on a scale
Standard Deviation 20.0
|
|
Joint Pain Visual Analog Score (VAS)
12 Weeks
|
11.3 score on a scale
Standard Deviation 18.8
|
|
Joint Pain Visual Analog Score (VAS)
6 Months
|
10.5 score on a scale
Standard Deviation 20.5
|
|
Joint Pain Visual Analog Score (VAS)
12 Months
|
11.8 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 monthsPopulation: Participants with available data necessary for the assessment specified for the given time frame.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=97 Participants
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.
|
|---|---|
|
Cosmetic Appearance Visual Analog Scale (VAS)
Preoperatively
|
39.8 score on a scale
Standard Deviation 33.8
|
|
Cosmetic Appearance Visual Analog Scale (VAS)
6 Weeks
|
71.1 score on a scale
Standard Deviation 23.8
|
|
Cosmetic Appearance Visual Analog Scale (VAS)
12 Weeks
|
75.4 score on a scale
Standard Deviation 25.4
|
|
Cosmetic Appearance Visual Analog Scale (VAS)
6 Months
|
78.1 score on a scale
Standard Deviation 25.5
|
|
Cosmetic Appearance Visual Analog Scale (VAS)
12 Months
|
83.0 score on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 monthsPopulation: Number analyzed for each specified time frame and category includes participants with available finger data.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=161 fingers
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.
|
|---|---|
|
Joint Position
12 Weeks · Subluxed
|
2 fingers
|
|
Joint Position
12 Weeks · Dislocated
|
0 fingers
|
|
Joint Position
12 Weeks · Missing
|
2 fingers
|
|
Joint Position
6 Months · Reduced
|
122 fingers
|
|
Joint Position
6 Months · Subluxed
|
2 fingers
|
|
Joint Position
6 Months · Dislocated
|
1 fingers
|
|
Joint Position
6 Months · Missing
|
6 fingers
|
|
Joint Position
12 Months · Reduced
|
118 fingers
|
|
Joint Position
12 Months · Subluxed
|
3 fingers
|
|
Joint Position
12 Months · Dislocated
|
0 fingers
|
|
Joint Position
12 Months · Missing
|
2 fingers
|
|
Joint Position
Preoperatively · Reduced
|
78 fingers
|
|
Joint Position
Preoperatively · Subluxed
|
62 fingers
|
|
Joint Position
Preoperatively · Dislocated
|
20 fingers
|
|
Joint Position
Preoperatively · Missing
|
1 fingers
|
|
Joint Position
6 Weeks · Reduced
|
152 fingers
|
|
Joint Position
6 Weeks · Subluxed
|
0 fingers
|
|
Joint Position
6 Weeks · Dislocated
|
2 fingers
|
|
Joint Position
6 Weeks · Missing
|
1 fingers
|
|
Joint Position
12 Weeks · Reduced
|
148 fingers
|
SECONDARY outcome
Timeframe: 6 Weeks, 12 Weeks, 6 Months, 12 MonthsPopulation: Number analyzed for each specified time frame and category includes participants with available implanted device data.
Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=155 devices
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.
|
|---|---|
|
Component Migration
6 Weeks · None
|
155 devices
|
|
Component Migration
6 Weeks · Yes
|
0 devices
|
|
Component Migration
6 Weeks · Missing
|
0 devices
|
|
Component Migration
12 Weeks · None
|
151 devices
|
|
Component Migration
12 Weeks · Yes
|
0 devices
|
|
Component Migration
12 Weeks · Missing
|
1 devices
|
|
Component Migration
6 Months · None
|
130 devices
|
|
Component Migration
6 Months · Yes
|
1 devices
|
|
Component Migration
6 Months · Missing
|
0 devices
|
|
Component Migration
12 Months · None
|
123 devices
|
|
Component Migration
12 Months · Yes
|
0 devices
|
|
Component Migration
12 Months · Missing
|
0 devices
|
SECONDARY outcome
Timeframe: 6 Weeks, 12 Weeks, 6 Months, 12 MonthsPopulation: Number analyzed for each specified time frame and category includes participants with available finger data.
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.
Outcome measures
| Measure |
Ascension® MCP Finger Implant
n=155 devices
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.
|
|---|---|
|
Bone Changes by Device
6 Weeks · None
|
154 devices
|
|
Bone Changes by Device
6 Weeks · Any Bone Changes
|
1 devices
|
|
Bone Changes by Device
6 Weeks · Missing
|
0 devices
|
|
Bone Changes by Device
12 Weeks · None
|
148 devices
|
|
Bone Changes by Device
12 Weeks · Any Bone Changes
|
3 devices
|
|
Bone Changes by Device
12 Weeks · Missing
|
1 devices
|
|
Bone Changes by Device
6 Months · None
|
103 devices
|
|
Bone Changes by Device
6 Months · Any Bone Changes
|
28 devices
|
|
Bone Changes by Device
6 Months · Missing
|
0 devices
|
|
Bone Changes by Device
12 Months · None
|
68 devices
|
|
Bone Changes by Device
12 Months · Any Bone Changes
|
52 devices
|
|
Bone Changes by Device
12 Months · Missing
|
3 devices
|
Adverse Events
Ascension® MCP Finger Implant
Serious events: 25 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ascension® MCP Finger Implant
n=97 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Ankylosing Spondylitis
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Deformity
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Deformity - Boutonniere
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Deformity - Swan Neck
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
DIP Mallet
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
DIP pin removal
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Renal and urinary disorders
Emergent Prostate Surgery
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Excessive Pain
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Flexion Contracture
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Flexion Contracture, tendon adhesion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Increased Stiffness
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Loss of Motion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Nervous system disorders
Numbness/Nerve Symptoms
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
OA Contralateral Hand
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
OA w/ midcarpal instability
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis w/ midcarpal instability
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Pain
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Pin Protrusion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Pin Removal
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
PIP Deformities
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Recurrent Radial Deviation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Recurrent Ulnar Deviation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Reduction/Loss of Motion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Removal of Kirschner wires
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Rupture
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Subluxation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Surgery on other hand
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Synovitis/Tenosynovitis
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Tendon Adhesion
|
3.1%
3/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Skin and subcutaneous tissue disorders
Wound Dehiscence
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
Other adverse events
| Measure |
Ascension® MCP Finger Implant
n=97 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
2.1%
2/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Back Surgery
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Blistering at tourniquet site
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Calcification PIP joint
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Cardiac disorders
Cardiovascular
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
2.1%
2/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Clicking, popping, pain in right middle finger
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Deformity
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Excessive Pain
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Excessive Swelling
|
3.1%
3/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Excessive Swelling
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Extension lag
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Flexion Contracture
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Gastrointestinal disorders
Gastrointestinal-Hospitalized for GI Bleed
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Increased Stiffness
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Infections and infestations
Infection - superficial
|
2.1%
2/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Lacerated EPB tendon
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Infections and infestations
Legionella infection
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Mild, clicking, popping, left index finger
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Nervous system disorders
Numbness/Nerve Symptoms
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Pain
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
General disorders
Pain Onset
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Pin Protrusion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Pin removal (L) Hand
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
PIP Revision surgery
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Recureent Radial/Ulnar Deviation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Recurrent Ulnar Deviation
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Reduction/loss of motion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Revision to another PyroCarbon MCP
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Ring & Small claw deformity
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Scar Adhesion
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Injury, poisoning and procedural complications
squeaking implant
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Stiffness in Left small finger
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Tendon Rupture
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Total Knee Replacement
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
|
Musculoskeletal and connective tissue disorders
Triggerfinger RR
|
1.0%
1/97 • Adverse events were collected from enrollment to study completion or termination, up to 1 year.
Adverse events were recorded on the appropriate Case Report Form. The investigator would inform the sponsor within 24 hours in the event of: * A severe, unexpected, device related complication or adverse event; or * A re-operation procedure for device removal or additional soft-tissue reconstruction.
|
Additional Information
Belinda Larson, Director, Global Clinical Strategy (Trauma)
Smith+Nephew, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place