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2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01284283
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Encore Medical, L.P.

Tracking Information
First Submitted Date  ICMJE November 2, 2010
First Posted Date  ICMJE January 26, 2011
Last Update Posted Date July 29, 2022
Study Start Date  ICMJE November 2009
Actual Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
Primary Endpoint [ Time Frame: 2 years ]
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as:
  1. ≥ 40 point improvement in total Buechel-Pappas Scale score
  2. No device failures
  3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration > 4mm)
  4. No major complications
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
The principal endpoint consists of evaluating the safety and effectiveness of the STAR Ankle using the same composite definition of patient success used in the IDE study. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
Secondary Endpoints [ Time Frame: 2 years ]
In addition to the principal endpoint, information on the following efficacy outcomes will be assessed:
  • Total Buechel-Pappas Scale score
  • Pain Visual Analog Scale
  • Quality of Life
  • American Orthopaedic Foot & Ankle Society (AOFAS) Ankle Hindfoot Scale
The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer:
  • Radiolucency
  • Migration
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
American Orthopaedic Foot and Ankle Society Score questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
Official Title  ICMJE 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Brief Summary This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Detailed Description This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Arthrosis
  • Post Traumatic Arthritis
  • Rheumatoid Arthritis
  • Osteoarthritis
Intervention  ICMJE Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Other Name: STAR
Study Arms  ICMJE Single
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Intervention: Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2018)
102
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
98
Actual Study Completion Date  ICMJE March 2021
Actual Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
  • Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
  • At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
  • Willing and able to give informed consent

Exclusion Criteria:

  • Patients who have not reached skeletal maturity
  • Active or prior deep infection inthe ankle joint or adjacent bones
  • Prior arthrodesis at the involved site
  • History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
  • Obesity (weight greater than 250 lbs)
  • History of current prior drug abuse or alcoholism
  • Any physical condition precluding major surgery
  • Hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot
  • Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
  • Avascular necrosis of the talus
  • Inadequate skin coverage above the ankle joint
  • Patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor
  • Juvenile onset Type I diabetes
  • Adult onset Type II diabetes when accompanied by neuropathic changes or a history of foot infection in either foot
  • Pregnancy
  • Avascular necrosis of the tibia
  • Significant bone tumor of the foot or ankle
  • Severe deformity that would not normally be eligible for ankle surgery
  • Prior surgery and/or injury that has adversely affected the ankle bone stock
  • Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
  • Insufficient ligament support
  • Motor dysfunction due to neuromuscular impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01284283
Other Study ID Numbers  ICMJE STAR 2 Year
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Encore Medical, L.P.
Original Responsible Party James O'Connor, Small Bone Innovations, Inc.
Current Study Sponsor  ICMJE Encore Medical, L.P.
Original Study Sponsor  ICMJE Small Bone Innovations, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stefan Maartense, MD Stryker Nordic
PRS Account Encore Medical, L.P.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP