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Business Priorities
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This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascension® MCP Finger Implant | Other | Single arm study, patient treated with Ascension® PyroCarbon MCP implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascension® MCP Finger Implant | Device | Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Revisions | Count of participants with a revision surgery. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperatively to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have any of the following contraindications will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Tummon | Sponsor- Integra LifeSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Shoulder Elbow and Hand Center, P.C. | Tucson | Arizona | 85712 | United States | ||
| Bloomington Bone and Joint Clinic |
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 recruited from 25 June 2002 to early termination on 03 January 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | Preoperatively to 12 months |
| Change in Grip Strength | Implanted hand grip strength measured using a grip dynamometer instrument. | 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 | 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. | 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. | 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. | 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. | 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. | 6 Weeks, 12 Weeks, 6 Months, 12 Months |
| Bloomington |
| Indiana |
| 47403 |
| United States |
| Reconstructive Hand Surgeons of Indiana | Carmel | Indiana | 46032 | United States |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| The Center for Ortho/ Neuro Care & Research | Bend | Oregon | 97701 | United States |
| ROC Houston, PA | Houston | Texas | 77004 | United States |
| Fondren Orthopedic Group, L.L.P. | Houston | Texas | 77030 | United States |
| The Hand Center of San Antonio | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
One bilateral participant enrolled in the study twice. The second enrollment was the contralateral hand after this participant completed the study.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| hands |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only data available for age used for analysis. | Mean | Standard Deviation | years | Participants |
|
| ||||||||||||||||||
| Sex: Female, Male | Count of Units | hands | hands |
|
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Unknown indicates queried data that returned nothing recorded on medical charts. 46 participants' information (47 hands) could not be retrieved due to site closure. | Count of Units | hands | hands |
|
| |||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
| ||||||||||||||||||||
| Number of Affected Joints | Number | joints | Participants |
|
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Revisions | Count of participants with a revision surgery. | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||
| 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. | Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified. | Posted | Mean | Standard Deviation | degrees | Preoperatively to 12 months | joints | joints |
|
| ||||||||||||||||||||||||
| 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. | Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified. | Posted | Mean | Standard Deviation | degrees | Preoperatively to 12 months | joints | joints |
|
| ||||||||||||||||||||||||
| 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. | Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified. | Posted | Mean | Standard Deviation | kilograms | Preoperatively to 12 months | joints | joints |
|
| ||||||||||||||||||||||||
| Secondary | Change in Grip Strength | Implanted hand grip strength measured using a grip dynamometer instrument. | Number of Participants Analyzed indicates overall population throughout the given time frame with any available joint data necessary for the assessment specified. | Posted | Mean | Standard Deviation | kilograms | Preoperatively to 12 months | joints | joints |
|
| ||||||||||||||||||||||||
| 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 | Participants with available data necessary for the assessment specified for the given time frame. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months |
|
| ||||||||||||||||||||||||||
| 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. | Participants with available data necessary for the assessment specified for the given time frame. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6 Weeks, 12 Weeks, 6 Months, 12 Months |
|
| ||||||||||||||||||||||||||
| 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. | Participants with available data necessary for the assessment specified for the given time frame. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 6 Weeks, 12 Weeks, 6 Months, and 12 months |
|
| ||||||||||||||||||||||||||
| 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. | Number analyzed for each specified time frame and category includes participants with available finger data. | Posted | Count of Units | fingers | Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months | fingers | fingers |
|
| |||||||||||||||||||||||||
| Secondary | Component Migration | Component migration determined by radiographic assessment. Migration of the device was classified as none, yes, or (data) missing. | Number analyzed for each specified time frame and category includes participants with available implanted device data. | Posted | Count of Units | devices | 6 Weeks, 12 Weeks, 6 Months, 12 Months | devices | devices |
|
| |||||||||||||||||||||||||
| 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. | Number analyzed for each specified time frame and category includes participants with available finger data. | Posted | Count of Units | devices | 6 Weeks, 12 Weeks, 6 Months, 12 Months | devices | devices |
|
|
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:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 97 | 25 | 97 | 30 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankylosing Spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Deformity - Boutonniere | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Deformity - Swan Neck | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| DIP Mallet | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| DIP pin removal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Emergent Prostate Surgery | Renal and urinary disorders | Systematic Assessment | Unrelated to device |
| |
| Excessive Pain | General disorders | Systematic Assessment | Unrelated to device |
| |
| Flexion Contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Flexion Contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flexion Contracture, tendon adhesion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Unrelated to device |
| |
| Increased Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Increased Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Increased Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Loss of Motion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
| |
| Numbness/Nerve Symptoms | Nervous system disorders | Systematic Assessment | Unrelated to device |
| |
| OA Contralateral Hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| OA w/ midcarpal instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Osteoarthritis w/ midcarpal instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Pain | General disorders | Systematic Assessment | Unrelated to device |
| |
| Pin Protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Pin Removal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| PIP Deformities | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Recurrent Radial Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
| |
| Reduction/Loss of Motion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Removal of Kirschner wires | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
| |
| Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
| |
| Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Surgery on other hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Synovitis/Tenosynovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to device |
| |
| Tendon Adhesion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated to device |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blistering at tourniquet site | General disorders | Systematic Assessment |
| ||
| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
| |
| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Calcification PIP joint | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| ||
| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Clicking, popping, pain in right middle finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Excessive Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
| |
| Excessive Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Excessive Swelling | General disorders | Systematic Assessment | Unrelated to device |
| |
| Excessive Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Extension lag | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Flexion Contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Gastrointestinal-Hospitalized for GI Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Increased Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Increased Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Infection - superficial | Infections and infestations | Systematic Assessment | Unrelated to device |
| |
| Lacerated EPB tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Legionella infection | Infections and infestations | Systematic Assessment | Unrelated to device |
| |
| Mild, clicking, popping, left index finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Numbness/Nerve Symptoms | Nervous system disorders | Systematic Assessment | Unrelated to device |
| |
| Pain | General disorders | Systematic Assessment | Unrelated to device |
| |
| Pain Onset | General disorders | Systematic Assessment | Unrelated to device |
| |
| Pin Protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Pin removal (L) Hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| PIP Revision surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Recureent Radial/Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Recurrent Ulnar Deviation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Reduction/loss of motion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly device related |
| |
| Revision to another PyroCarbon MCP | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ring & Small claw deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
| |
| Scar Adhesion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| squeaking implant | Injury, poisoning and procedural complications | Systematic Assessment | Device Related |
| |
| Stiffness in Left small finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Tendon Rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
| |
| Total Knee Replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Triggerfinger RR | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to device |
|
Study early terminated by Integra LifeSciences due to poor follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Belinda Larson, Director, Global Clinical Strategy (Trauma) | Smith+Nephew, Inc. | belinda.larson@smith-nephew.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D001327 | Autoimmune Diseases |
| D003240 | Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Title | Measurements |
|---|
| Female |
|
| Male |
|
| Race/Ethnicity |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| joints |
|
|
| joints |
|
|
| joints |
|
|
| joints |
|
|
|
|
|
| fingers |
|
|
| devices |
|
|
| devices |
|
|
| Dislocated |
|
| Missing |
|
| Dislocated |
|
| Missing |
|
| Dislocated |
|
| Missing |
|
| Dislocated |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
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| Missing |
|