NCT01284283

Brief Summary

This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

11.3 years

First QC Date

November 2, 2010

Last Update Submit

July 27, 2022

Conditions

Primary ArthrosisPost Traumatic ArthritisRheumatoid ArthritisOsteoarthritis

Keywords

ArthrosisRheumatoid ArthrosisArthritic JointRheumatoid ArthritisOsteoarthritisTotal Ankle Replacement

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint

    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

    2 years

Secondary Outcomes (1)

  • Secondary Endpoints

    2 years

Study Arms (1)

Single

OTHER

Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Interventions

Scandinavian Total Ankle Replacement System (STAR Ankle)DEVICE

For total ankle replacement

Also known as: STAR
Single

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The CORE Institute

Phoenix, Arizona, 85023, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Palo Alto Medical Research Foundation (Sutter Health)

Palo Alto, California, 94301, United States

Location

Kaiser Permanente

San Francisco, California, 94118, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48085, United States

Location

Reno Orthopaedic Center

Reno, Nevada, 89503, United States

Location

Kenneth Mroczek, MD-NYU

New York, New York, 10003, United States

Location

University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons

Philadelphia, Pennsylvania, 19106, United States

Location

Center for Foot and Ankle Restoration

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Stefan Maartense, MD

    Stryker Nordic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

January 26, 2011

Study Start

November 1, 2009

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(9)