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InSpace Accelerated Rehabilitation Study (iAccelerate)

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InSpace Subacromial Tissue Spacer
Sponsored by
Stryker Endoscopy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects MUST meet ALL the following criteria to be included in the study:

  • The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
  • Is male or female ≥ sixty-five (65) years of age
  • Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT:

    • Measuring ≥ 5 cm in diameter
    • Involving ≥ two tendons
  • Functional deltoid muscle and preserved passive range of motion on physical examination
  • Documented VAS score > 30 mm pain
  • Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following:

    • Oral analgesics
    • Anti-inflammatory medication (e.g., ibuprofen, naproxen)
    • Corticosteroid injection(s)
    • Physical therapy
    • Activity modification
    • Rest (sling used)
  • Must be able to read and understand the approved Informed Consent Form (written and oral)
  • Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
  • Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection

Intra-operative Inclusion Criteria

Subjects MUST meet the following criteria to be randomized in the study:

  • Full thickness tear
  • Tear size ≥ 5 cm in diameter
  • Tear involving ≥ two tendons

Exclusion Criteria:

Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria:

  • Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
  • Evidence of the following conditions:

    • Severe gleno-humeral or acromio-humeral arthritis
    • Full thickness cartilage loss as seen on MRI
    • History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
    • Pre-existing deltoid defect or deltoid palsy
    • Major joint trauma, infection, or necrosis
    • Partial thickness tears of the supraspinatus
    • Fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]
    • Known neurovascular compromise
    • Complete deltoid muscle palsy
    • Traumatic muscle tears of the pectoralis or deltoid
  • The subject requires concomitant:

    • Subscapularis repair
    • Labral repair of any type
    • Biceps tenodesis
  • Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
  • The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
  • Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis)
  • The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
  • The subject's condition represents a worker's compensation case
  • The subject is currently involved in a health-related litigation procedure
  • Females of child-bearing potential who are pregnant or plan to become pregnant.
  • Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period
  • The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
  • The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
  • The subject currently has an acute infection in the area surrounding the surgical site.
  • Baseline WORC score less than 420

Intra-operative Exclusion Criteria:

Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria:

  • Rotator cuff is/presents with:

    • Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2)
    • Partial thickness tear of the supraspinatus
    • Evidence of significant osteoarthritis
  • The subject requires concomitant:

    • Subscapularis repair
    • Labral repair of any type
    • Biceps tenodesis
  • Coracoacromial ligament functional deficiency or shoulder instability is identified

Sites / Locations

  • Musculoskeletal-Orthopedic Research and Education FoundationRecruiting
  • UC DenverRecruiting
  • Holy Cross HospitalRecruiting
  • Paley Orthopaedics & SpineRecruiting
  • Emory UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • Mayo ClinicRecruiting
  • Hospital for Special SurgeryRecruiting
  • The Rothman InstituteRecruiting
  • TSAOG Orthopaedics & SpineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

InSpace device + accelerated rehabilitation in a formalized program (FP)

InSpace device + accelerated rehabilitation in an at-home program (AHP)

Outcomes

Primary Outcome Measures

Change in American Shoulder and Elbow (ASES) Score
This is a subject self-report questionnaire and Investigator assessment questionnaire. The subject portion collects information on activities of daily living (i.e., 10 questions). The Investigator assessment portion documents ROM (forward elevation/flexion, external rotation, internal rotation, cross-body adduction), signs, strength, and instability. ASES minimal clinical important difference (MCID) and substantial clinical benefit (SCB) have been previously described for the ASES score in patients undergoing rotator cuff repair as 11.1 and 17.5, respectively. Change in American Shoulder and Elbow Surgeons (ASES) Score will be expressed as the percentages demonstrating a minimal clinical important difference (MCID; ASES ≥ 11.1) and the substantial clinical benefit (SCB; ASES ≥ 17.5) in ASES from baseline at Month 12. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).

Secondary Outcome Measures

Safety Assessment
• Safety will be evaluated by type, frequency, severity, and relatedness of adverse events to study intervention at each follow-up visit through Month 24
Change in Western Ontario Rotator Cuff (WORC) Score
Change in WORC Score from baseline. Minimum value: 2,100, Maximum value: 0 (with a lower score indicating a better outcome). This is a subject self-report questionnaire that is a disease-specific Quality of Life Measurement Tool specifically designed to evaluate quality of life in persons with pathology of the rotator cuff. It is comprised of 21 items in 5 domains (i.e., physical symptoms, sports and recreation, work, lifestyle, emotions).
Change in Constant Score (CS) Outcome Score
Change in CS Outcome Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a self-reported questions as well as Investigator or designee performed assessment of the shoulder. The tool is divided into four subscales: pain, activities of daily living, strength and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder.
Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score
Change in EQ-5D-5L Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a subject self-report questionnaire to measure health-related quality of life (HRQOL). It consists of 5 questions capturing the subject's current health across five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a numerical visual analogue scale (EQ-VAS).
Change in Visual Analog Scale (VAS) Score
Change in VAS Score from baseline. This is a subject self-report questionnaire to measure pain. The patient marks on the line the point that they feel represents their perception of their current state. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. (An extreme amount of pain would be considered a worse outcome)
Change in Range of Motion (ROM) Score
Change in ROM Score from baseline. Minimum value: 0, Maximum value: 180 (with a higher score indicating a better outcome).
Change in Single Assessment Numeric Evaluation (SANE) Score
Change in SANE from baseline. Minimum value: 0%, Maximum value: 100% (with 100% being normal). This is a subject self-report questionnaire to measure function. The patient marks on the line the point that they feel represents their perception of their current state of functional improvement. Example: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Patient's satisfaction with their procedure
Patient Satisfaction Score at Month 12 and Month 24. This is a single-question to evaluate the patients' current state of satisfaction. Responses are binary with Yes or No answers. ('Yes' would be considered a positive outcome)
Costing
Costs associated with all visits
Time to Recovery
Time to recovery by cumulative time between discharge and return to driving
Analgesia Use
Analgesia use (drug and frequency)

Full Information

First Posted
March 17, 2022
Last Updated
August 1, 2023
Sponsor
Stryker Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT05329584
Brief Title
InSpace Accelerated Rehabilitation Study
Acronym
iAccelerate
Official Title
An Assessment of Two Accelerated Rehabilitation Programs for Use With the InSpaceTM Subacromial Tissue Spacer System in the Treatment of Full-thickness Massive, Irreparable Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Endoscopy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.
Detailed Description
Study Objectives: Primary: • To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results. To demonstrate consistency of each intervention group with the corresponding historical control study results. To demonstrate that comparable clinical outcomes can be achieved for each intervention group. Secondary: • Change in clinical outcomes compared to baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
InSpace device + accelerated rehabilitation in a formalized program (FP)
Arm Title
Group II
Arm Type
Experimental
Arm Description
InSpace device + accelerated rehabilitation in an at-home program (AHP)
Intervention Type
Device
Intervention Name(s)
InSpace Subacromial Tissue Spacer
Intervention Description
Rotator Cuff Tear Treatment
Primary Outcome Measure Information:
Title
Change in American Shoulder and Elbow (ASES) Score
Description
This is a subject self-report questionnaire and Investigator assessment questionnaire. The subject portion collects information on activities of daily living (i.e., 10 questions). The Investigator assessment portion documents ROM (forward elevation/flexion, external rotation, internal rotation, cross-body adduction), signs, strength, and instability. ASES minimal clinical important difference (MCID) and substantial clinical benefit (SCB) have been previously described for the ASES score in patients undergoing rotator cuff repair as 11.1 and 17.5, respectively. Change in American Shoulder and Elbow Surgeons (ASES) Score will be expressed as the percentages demonstrating a minimal clinical important difference (MCID; ASES ≥ 11.1) and the substantial clinical benefit (SCB; ASES ≥ 17.5) in ASES from baseline at Month 12. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).
Time Frame
Day 0 through Month 12
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
• Safety will be evaluated by type, frequency, severity, and relatedness of adverse events to study intervention at each follow-up visit through Month 24
Time Frame
Day 0 through Month 24
Title
Change in Western Ontario Rotator Cuff (WORC) Score
Description
Change in WORC Score from baseline. Minimum value: 2,100, Maximum value: 0 (with a lower score indicating a better outcome). This is a subject self-report questionnaire that is a disease-specific Quality of Life Measurement Tool specifically designed to evaluate quality of life in persons with pathology of the rotator cuff. It is comprised of 21 items in 5 domains (i.e., physical symptoms, sports and recreation, work, lifestyle, emotions).
Time Frame
Day 0 through Month 24
Title
Change in Constant Score (CS) Outcome Score
Description
Change in CS Outcome Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a self-reported questions as well as Investigator or designee performed assessment of the shoulder. The tool is divided into four subscales: pain, activities of daily living, strength and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder.
Time Frame
Day 0 through Month 24
Title
Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score
Description
Change in EQ-5D-5L Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a subject self-report questionnaire to measure health-related quality of life (HRQOL). It consists of 5 questions capturing the subject's current health across five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a numerical visual analogue scale (EQ-VAS).
Time Frame
Day 0 through Month 24
Title
Change in Visual Analog Scale (VAS) Score
Description
Change in VAS Score from baseline. This is a subject self-report questionnaire to measure pain. The patient marks on the line the point that they feel represents their perception of their current state. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. (An extreme amount of pain would be considered a worse outcome)
Time Frame
Day 0 through Month 24
Title
Change in Range of Motion (ROM) Score
Description
Change in ROM Score from baseline. Minimum value: 0, Maximum value: 180 (with a higher score indicating a better outcome).
Time Frame
Day 0 through Month 24
Title
Change in Single Assessment Numeric Evaluation (SANE) Score
Description
Change in SANE from baseline. Minimum value: 0%, Maximum value: 100% (with 100% being normal). This is a subject self-report questionnaire to measure function. The patient marks on the line the point that they feel represents their perception of their current state of functional improvement. Example: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Time Frame
Day 0 through Month 24
Title
Patient's satisfaction with their procedure
Description
Patient Satisfaction Score at Month 12 and Month 24. This is a single-question to evaluate the patients' current state of satisfaction. Responses are binary with Yes or No answers. ('Yes' would be considered a positive outcome)
Time Frame
Month 12 and Month 24
Title
Costing
Description
Costs associated with all visits
Time Frame
Day 0 through Month 24
Title
Time to Recovery
Description
Time to recovery by cumulative time between discharge and return to driving
Time Frame
Day 0 through Month 24
Title
Analgesia Use
Description
Analgesia use (drug and frequency)
Time Frame
Day 0 through Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects MUST meet ALL the following criteria to be included in the study: The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment Is male or female ≥ sixty-five (65) years of age Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT: Measuring ≥ 5 cm in diameter Involving ≥ two tendons Functional deltoid muscle and preserved passive range of motion on physical examination Documented VAS score > 30 mm pain Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following: Oral analgesics Anti-inflammatory medication (e.g., ibuprofen, naproxen) Corticosteroid injection(s) Physical therapy Activity modification Rest (sling used) Must be able to read and understand the approved Informed Consent Form (written and oral) Must be in general good health (as determined by the Investigator) based on screening assessments and medical history Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection Intra-operative Inclusion Criteria Subjects MUST meet the following criteria to be randomized in the study: Full thickness tear Tear size ≥ 5 cm in diameter Tear involving ≥ two tendons Exclusion Criteria: Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria: Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone) Evidence of the following conditions: Severe gleno-humeral or acromio-humeral arthritis Full thickness cartilage loss as seen on MRI History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings Pre-existing deltoid defect or deltoid palsy Major joint trauma, infection, or necrosis Partial thickness tears of the supraspinatus Fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired] Known neurovascular compromise Complete deltoid muscle palsy Traumatic muscle tears of the pectoralis or deltoid The subject requires concomitant: Subscapularis repair Labral repair of any type Biceps tenodesis Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder Major medical condition that could affect quality of life and influence the results of the study (e.g., rheumatoid arthritis) The subject has documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment The subject's condition represents a worker's compensation case The subject is currently involved in a health-related litigation procedure Females of child-bearing potential who are pregnant or plan to become pregnant. Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition The subject currently has an acute infection in the area surrounding the surgical site. Baseline WORC score less than 420 Intra-operative Exclusion Criteria: Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria: Rotator cuff is/presents with: Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2) Partial thickness tear of the supraspinatus Evidence of significant osteoarthritis The subject requires concomitant: Subscapularis repair Labral repair of any type Biceps tenodesis Coracoacromial ligament functional deficiency or shoulder instability is identified
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayley Taylor, MS
Phone
805-705-4206
Email
hayley.taylor@stryker.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Roden, MS
Organizational Affiliation
Stryker Endoscopy
Official's Role
Study Director
Facility Information:
Facility Name
Musculoskeletal-Orthopedic Research and Education Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wafa Mohsin
Email
wafa.mohsin@more-foundation.org
First Name & Middle Initial & Last Name & Degree
Michael Amini, MD
First Name & Middle Initial & Last Name & Degree
Michael Rose, MD
First Name & Middle Initial & Last Name & Degree
John Brown, MD
Facility Name
UC Denver
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Orahovats
Email
alexandra.orahovats@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
James Genuario
First Name & Middle Initial & Last Name & Degree
Brayden Mayer
First Name & Middle Initial & Last Name & Degree
Martin Boublik
First Name & Middle Initial & Last Name & Degree
Thomas Noonan
First Name & Middle Initial & Last Name & Degree
Adam Seidl
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Henderson
Email
David.Henderson002@holy-cross.com
First Name & Middle Initial & Last Name & Degree
Ross Wodika, MD
Facility Name
Paley Orthopaedics & Spine
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice Schuck
Email
janice.schuck@tenehealth.com
First Name & Middle Initial & Last Name & Degree
Jonathan Levy, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Vernon
Email
isabelle.m.vernon@emory.edu
First Name & Middle Initial & Last Name & Degree
Eric Wagner, MD
First Name & Middle Initial & Last Name & Degree
Michael Gottschalk, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kavita Ahuja
Email
kavita.ahuja@rushortho.com
First Name & Middle Initial & Last Name & Degree
Mukesh Ahuja
Email
Mukesh.Ahuja@rushortho.com
First Name & Middle Initial & Last Name & Degree
Nikhil Verma, MD
First Name & Middle Initial & Last Name & Degree
Gregory Nicholson, MD
First Name & Middle Initial & Last Name & Degree
Brian Cole, MD
First Name & Middle Initial & Last Name & Degree
Grant Garrigues, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Hobbs
Email
hobbs.lindsey@mayo.edu
First Name & Middle Initial & Last Name & Degree
Joaquin Sanchez Sotelo
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Finocchiaro
Email
finocchiaroa@hss.edu
First Name & Middle Initial & Last Name & Degree
Michael Fu, MD
First Name & Middle Initial & Last Name & Degree
Joshua Dines, MD
Facility Name
The Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thema Nicholson
Email
thema.nicholson@rothmanortho.com
First Name & Middle Initial & Last Name & Degree
Joseph Abboud, MD
Facility Name
TSAOG Orthopaedics & Spine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Proffitt
Email
mproffitt@tsaog.com
First Name & Middle Initial & Last Name & Degree
Robert Hartzler, MD
First Name & Middle Initial & Last Name & Degree
Lane Naugher, MD
First Name & Middle Initial & Last Name & Degree
Sergio Viroslav, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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InSpace Accelerated Rehabilitation Study

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