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

Rheumatoid Arthritis Clinical Trial

— MCP  

Official title:

Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02408471
• Other study ID #: CP-MCP-002
• Status: Terminated
• Phase: N/A
• Start date: June 2002
• Est. completion date: January 2015

Study information

• Verified date: August 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01398735

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lupus Erythematosus, Systemic
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Intervention

Device:
• Ascension® MCP Finger Implant
Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Locations

Country	Name	City	State
United States	The Center for Ortho/ Neuro Care & Research	Bend	Oregon
United States	Bloomington Bone and Joint Clinic	Bloomington	Indiana
United States	Reconstructive Hand Surgeons of Indiana	Carmel	Indiana
United States	Fondren Orthopedic Group, L.L.P.	Houston	Texas
United States	ROC Houston, PA	Houston	Texas
United States	The Indiana Hand Center	Indianapolis	Indiana
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	The Hand Center of San Antonio	San Antonio	Texas
United States	Southwest Shoulder Elbow and Hand Center, P.C.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Revisions	Count of participants with a revision surgery.	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.	Preoperatively to 12 months
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.	Preoperatively to 12 months
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.	Preoperatively to 12 months
Secondary	Change in Grip Strength	Implanted hand grip strength measured using a grip dynamometer instrument.	Preoperatively to 12 months
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	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.	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.	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.	Preoperatively, 6 weeks, 12 weeks, 6 months, and 12 months
Secondary	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
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.	6 Weeks, 12 Weeks, 6 Months, 12 Months