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

Sponsor

Integra LifeSciences Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT02408471

Collaborator

(none)

Enrollment

Locations

Arm

179

Actual Duration (Months)

10.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Systemic Lupus Erythematosus Osteoarthritis Post-traumatic Arthritis	Device: Ascension® MCP Finger Implant	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Ascension® MCP Finger Implant Single arm study, patient treated with Ascension® PyroCarbon MCP implant.	Device: Ascension® MCP Finger Implant Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Arm

Intervention/Treatment

Other: Ascension® MCP Finger Implant

Single arm study, patient treated with Ascension® PyroCarbon MCP implant.

Device: Ascension® MCP Finger Implant

Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.

Outcome Measures

Primary Outcome Measures

Rate of revision [One year]

Secondary Outcome Measures

Improvement in joint range of motion from baseline [One year]
Range of motion measured by clinical assessment
Improvement in grip strength from baseline [One year]
Grip strength measured by dynometer
Improvement in patient satisfaction as measured by the visual analog scale [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Shoulder Elbow and Hand Center, P.C.	Tucson	Arizona	United States	85712
2	Bloomington Bone and Joint Clinic	Bloomington	Indiana	United States	47403
3	Reconstructive Hand Surgeons of Indiana	Carmel	Indiana	United States	46032
4	The Indiana Hand Center	Indianapolis	Indiana	United States	46260
5	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
6	The Center for Ortho/ Neuro Care & Research	Bend	Oregon	United States	97701
7	ROC Houston, PA	Houston	Texas	United States	77004
8	Fondren Orthopedic Group, L.L.P.	Houston	Texas	United States	77030
9	The Hand Center of San Antonio	San Antonio	Texas	United States	78229