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A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

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: NCT02493660
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : July 22, 2021
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Rotator Cuff Syndrome
Interventions Device: InSpace sub-acromial tissue spacer system
Procedure: Partial repair of rotator cuff
Enrollment 184
Recruitment Details Subjects assessed for eligibility n=229
Pre-assignment Details Subjects excluded (n=45) for various reasons, not meeting criteria (n=11), declined to participate (n=12), and Other (n=22) such as, no medical clearance for surgery, intra-op screen failures, enrollment full.
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Period Title: Overall Study
Started 93 [1] 91 [1]
Completed 83 79 [2]
Not Completed 10 12
Reason Not Completed
Physician Decision             0             1
Adverse Event             4             2
Withdrawal by Subject             2             3
Subject unable to return for follow-up visits             2             0
Protocol Violation             0             1
Death             0             1
Lost to Follow-up             2             4
[1]
ITT
[2]
Investigator requested subject be discontinued prior to any post-procedure efficacy assessments.
Arm/Group Title InSpace Implantation Tendon Repair Total
Hide Arm/Group Description

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Total of all reporting groups
Overall Number of Baseline Participants 93 91 184
Hide Baseline Analysis Population Description
Number of subjects who were randomized and received an InSpace implant and the number of subjects who received a Partial Repair of their rotator cuff.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 184 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  40.9%
44
  48.4%
82
  44.6%
>=65 years
55
  59.1%
47
  51.6%
102
  55.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 91 participants 184 participants
66.8  (7.70) 64.7  (7.88) 65.8  (7.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 184 participants
Female
43
  46.2%
41
  45.1%
84
  45.7%
Male
50
  53.8%
50
  54.9%
100
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 184 participants
Hispanic or Latino
2
   2.2%
2
   2.2%
4
   2.2%
Not Hispanic or Latino
91
  97.8%
89
  97.8%
180
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 184 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.1%
1
   1.1%
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   7.5%
7
   7.7%
14
   7.6%
White
83
  89.2%
80
  87.9%
163
  88.6%
More than one race
2
   2.2%
3
   3.3%
5
   2.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 184 participants
Canada 15 12 27
United States 78 78 156
1.Primary Outcome
Title Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.
Hide Description

The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).

The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.

Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of participants in the Per Protocol Population (PP) with surgical treatment success of the InSpace device as a Primary surgical treatment for Full-thickness massive rotator cuff tears (MRCT).
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:
InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Unit of Measure: percentage of participants
51.1 39.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection InSpace Implantation, Tendon Repair
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Regression, Logistic
Comments Primary analysis method was for month 12 success with age (<65 years, ≥65 years), sex, and treatment as the model covariates.
2.Secondary Outcome
Title Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24
Hide Description Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).
Time Frame Baseline through to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population with no major protocol deviations.
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Overall Number of Participants Analyzed 82 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.3
(35.5 to 57.1)
38.0
(27.0 to 49.0)
3.Secondary Outcome
Title Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Hide Description The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).
Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:
InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Unit of Measure: percentage of participants
89.8 87.5
4.Secondary Outcome
Title Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
Hide Description

The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..

The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.

Time Frame Baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:
InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Number of Participants Analyzed 88 88
Measure Type: Number
Unit of Measure: percentage of participants
96.3 90.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection InSpace Implantation, Tendon Repair
Comments Results from logistic regression model.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was 10% for all composite endpoints.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC
Hide Description The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.
Time Frame Baseline through to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent To Treat (ITT) population with available data.
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:
InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Number of Participants Analyzed 83 78
Mean (Full Range)
Unit of Measure: score on a scale
-1083.37
(-1199.94 to -966.81)
-1007.00
(-1108.34 to -905.67)
6.Secondary Outcome
Title Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES
Hide Description

Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.

The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.

Time Frame Baseline through to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) Population with available data
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:
InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
Overall Number of Participants Analyzed 83 79
Mean (Full Range)
Unit of Measure: score on a scale
46.22
(41.66 to 50.79)
42.53
(37.96 to 47.10)
7.Secondary Outcome
Title Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Hide Description The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.
Time Frame Baseline to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population with available data
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Overall Number of Participants Analyzed 83 79
Mean (Full Range)
Unit of Measure: score on a scale
28.22
(23.92 to 32.51)
21.81
(16.99 to 26.63)
8.Secondary Outcome
Title The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Hide Description The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.
Time Frame Baseline through to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population with available data
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Overall Number of Participants Analyzed 83 78
Mean (Full Range)
Unit of Measure: score on a scale
-4.65
(-5.36 to -3.94)
-4.00
(-4.61 to -3.39)
9.Secondary Outcome
Title Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Hide Description The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.
Time Frame Baseline through to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) Population with available data
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Overall Number of Participants Analyzed 83 78
Mean (Full Range)
Unit of Measure: score on a scale
-56.55
(-61.78 to -51.32)
-54.55
(-59.92 to -49.19)
10.Secondary Outcome
Title Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears
Hide Description The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.
Time Frame Baseline through to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population with available data
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description:

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

Overall Number of Participants Analyzed 82 77
Mean (Full Range)
Unit of Measure: score on a scale
36.89
(28.02 to 45.76)
18.16
(9.33 to 26.98)
Time Frame Collected over 12 months and 24 months visit.
Adverse Event Reporting Description The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
 
Arm/Group Title InSpace Implantation Tendon Repair
Hide Arm/Group Description

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Arthroscopic partial repair of rotator cuff

Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff

All-Cause Mortality
InSpace Implantation Tendon Repair
Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)      1/91 (1.10%)    
Hide Serious Adverse Events
InSpace Implantation Tendon Repair
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/93 (23.66%)      22/91 (24.18%)    
Cardiac disorders     
eg. Multi-vessel Coronary Artery Disease * 1 [1]  1/93 (1.08%)  1 0/91 (0.00%)  0
Angina Pectoris (Chest pain-Cardiac)  1  0/93 (0.00%)  0 1/91 (1.10%)  1
Atrial Fibrillation * 1 [1]  1/93 (1.08%)  1 0/91 (0.00%)  0
Cardiac Arrest * 1 [1]  1/93 (1.08%)  1 0/91 (0.00%)  0
Gastrointestinal disorders     
eg. Gastrointestinal haemorrhage, short-bowel syndrome, small intestinal obstruction * 1  2/93 (2.15%)  4 0/91 (0.00%)  0
General disorders     
eg. Event leading to Death, non-cardiac chest pain, surgical failure * 1  0/93 (0.00%)  0 3/91 (3.30%)  3
Musculoskeletal and connective tissue disorders     
eg. Pain or inflammation * 1 [2]  10/93 (10.75%)  11 11/91 (12.09%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
eg.Prostate cancer, leukemia, Parathyroid tumor * 1  3/93 (3.23%)  4 4/91 (4.40%)  4
Nervous system disorders     
eg. dizziness, Aphasia, Cerebrovascular accident * 1  4/93 (4.30%)  6 2/91 (2.20%)  3
Respiratory, thoracic and mediastinal disorders     
eg.Laryngeal granuloma, Chronic obstructive pulmonary disease, pulmonary mass * 1  3/93 (3.23%)  3 1/91 (1.10%)  1
1
Term from vocabulary, System Organ Class
*
Indicates events were collected by non-systematic assessment
[1]
Same subject can have more than one event.
Indicates events were collected by systematic assessment
[2]
All body areas reported
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
InSpace Implantation Tendon Repair
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/93 (72.04%)      69/91 (75.82%)    
Cardiac disorders     
Atrial fibrillation * 1 [1]  2/93 (2.15%)  2 1/91 (1.10%)  1
Tachycardia * 1  2/93 (2.15%)  2 0/91 (0.00%)  0
Pre-Ventricular Contractions * 1  1/93 (1.08%)  1 0/91 (0.00%)  0
Gastrointestinal disorders     
Constipation * 1  6/93 (6.45%)  10 6/91 (6.59%)  6
General disorders     
Pain, Local swelling * 1  10/93 (10.75%)  12 5/91 (5.49%)  5
Infections and infestations     
UTI, Bronchitis, pneumonia * 1  16/93 (17.20%)  23 11/91 (12.09%)  13
Injury, poisoning and procedural complications     
Fall and injury, meniscus injury, Tendon rupture (anywhere in body) * 1  13/93 (13.98%)  18 22/91 (24.18%)  23
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain, Arthralgia, back pain (anywhere in body) * 1 [2]  51/93 (54.84%)  96 48/91 (52.75%)  71
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma * 1  7/93 (7.53%)  8 4/91 (4.40%)  4
Nervous system disorders     
Headache, dizziness * 1  10/93 (10.75%)  14 10/91 (10.99%)  12
1
Term from vocabulary, System Organ Class
*
Indicates events were collected by non-systematic assessment
[1]
Note: Some subjects may have more than one event.
[2]
Note: One subject may have more than one event in all of these categories.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and can only extend the embargo with patent protection review.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Colleen Roden, Director, Clinical Operations
Organization: Stryker Company
Phone: 1 931 267 2041
EMail: colleen.roden@stryker.com
Layout table for additonal information
Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT02493660    
Other Study ID Numbers: CLD-OR-010
First Submitted: July 1, 2015
First Posted: July 9, 2015
Results First Submitted: May 19, 2021
Results First Posted: July 22, 2021
Last Update Posted: June 15, 2022