Rotator Cuff TearNCT00456781
Use of Graft Jacket for Rotator Cuff Repair
A study testing Augmentation and Rotator Cuff Repair without augmentation in people with Rotator Cuff Tear, run by Stryker Trauma and Extremities at 7 sites in 2 countries.
Trial summary
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Augmentation and Rotator Cuff Repair without augmentation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 - 75 years inclusive,
- Reads, understand and able to complete the patient reported outcomes in English,
- Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
- Patients with either primary or revision rotator cuff tears measuring < 5cm with at least 2 tendon involvement as indicated by MRI,
- Patients who have a reasonable movement of the non-operative arm, defined as a shoulder elevation of equal or more than 90°, and are able to perform (postoperative) exercises,
- Patients for whom there is a reasonable expectation that he or she will be available for each protocol required post-operative follow-up examination,
- Patients must complete the informed consent process (including any regulatory requirements such as HIPAA authorization) agreeing to participate and signing the informed consent form prior to the site conducting any study related procedures.
Who cannot join
- Patients with irreparable large or massive rotator cuff tears <3cm will be excluded if found intra-operatively
- Patients with rotator cuff tears where the subscapularis tendon is disrupted,
- Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
- Patients with evidence of active infection, cancer, or highly communicable diseases that would preclude the patient from completing required patient assessments and clinic visits as described in the protocol,
- Patients who smoke,
- Patients with a documented history of drug abuse within six months of treatment,
- Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.
- Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
Bone and Joint Clinic of Houston
Houston, Texas, 77005
Kelsey-Seybold Orthopedic
Houston, Texas, 77025
Plano Orthopedic & Sports Medicine
Plano, Texas, 75093
Southern California Orthopedic Institute
Simi Valley, California, 93063
Canada3 sites
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7
The Hand and Upper Limb Centre
London, Ontario, NSA-4L6
Pan Am Clinic
Winnipeg, Manitoba, RM3-3E4
About this study
Official title: GraftJacket® Rotator Cuff Tendon Reinforcement Scaffold: A Randomized Prospective Clinical Evaluation
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpose of this study is to determine whether rotator cuff repair augmentation using GraftJacket allograft provides a viable alternative, based on observed clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The study will secondarily investigate the difference in outcomes in patients treated arthroscopically versus open. This study will report patient progress and results at early (6 month) and late (2 year) time points in patients treated for large and massive reparable rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and re-tear rate will be included in the study evaluations.
Read the detailed description
This is a prospective multi-center clinical study evaluating GraftJacket in the augmentation of large and massive rotator cuff tears compared to the traditional surgical technique of sutures and anchors alone. The study group will consist of 160 patients (early withdrawals or drop outs will not be replaced). Surgical approach for each patient will be either mini-open or arthroscopic. Safety assessments for this clinical study will be based on reported adverse events. Any adverse event that occurs during the study that represents a change from the patient's condition as noted at baseline [determined by normal standard of care] that is related to the procedure will be documented by completing the adverse events case report form.
Each investigator will indicate which operative technique (mini-open or arthroscopic) will be used during the study period at their site. The site selection process will be used to attempt to attain an equal distribution of both operative techniques used in the study. Patients will be randomly assigned to the treatment groups A or B. A randomization scheme using a 2 block model will be used within each surgical technique. Randomization cards meeting the requirements for this process will be generated by the statistician. Both surgical technique treatment groups will use the same assessments for comparisons throughout the study period.
Enrollment Plan for the GraftJacket Rotator Cuff Tendon Reinforcement Scaffold Surgical Technique Open Surgical (suture and anchor) Arthroscopic Group A without augmentation Group B with GraftJacket Group A without augmentation Group B with GraftJacket
Patients with reparable rotator cuff repairs must present with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery to be eligible for enrollment. A reparable rotator cuff tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. It should be possible to accomplish a watertight repair or only leave a residual defect of less than or equal to 1cm. The anteroposterior and mediolateral dimensions of the rotator cuff tear will be assessed intra-operatively by measurements either including the edges or after the edges are trimmed depending on the judgment of the surgeon. Rotator cuff tears involving the subscapularis tendon will not be included in the study, because the postoperative rehabilitation is more difficult and may confound the outcome results of either group. Surgical variables that should be documented on source documents and appropriate CRFs are the size of rotator cuff tear, the number of tendons involved, the type of repair (open, mini-open, arthroscopic) and the type and number of sutures and anchors.
Both clinical assessments and magnetic resonance imaging will be used to evaluate the effectiveness of the surgical techniques in both groups A and B. A screen/baseline MRI will be obtained of the affected shoulder during the preoperative visit. This MRI will be used to evaluate the extent of involvement and determine suitability for enrollment into the study including the size of the tear and extent of muscle atrophy. Images obtained within 3 months of signing consent may be used to assess eligibility for enrollment. Three additional follow-up MRIs of the affected shoulder will be obtained as part of the 2 year post-operative evaluation and will be used to evaluate structural success of group A, suture and anchor or group B, GraftJacket® allograft augmentation. The MRI scans performed at 6 months, 12 months and 24 months will be used to determine the rate of re-tear and to help to assess the integrity of the rotator cuff. Re-tears which are evident on the 6-month MRI will be considered a failure of the surgical technique, will be excluded from further follow-up within the study and followed separately. The comparison of the proportions of re-tears in patients in groups A and B who complete the MRI regimen through 2 years will be used to determine if GraftJacket® augmentation is a viable alternative to suture and anchor.
The Investigator will use clinical, functional, radiological, assessment of adverse events and assessment of the surgical techniques of groups A or B to evaluate each patient enrolled in this clinical study.
Pre Operative Procedures - Screen (Baseline)
Screening activities are performed during Visit 1. The protocol requires the following assessments during that visit:
- Informed consent process completed before any study related activities begin
- Inclusion/Exclusion criteria evaluation for study entry qualifications
- Magnetic Resonance Imaging (MRI)
- American Shoulder and Elbow Society (ASES) Scale
- University California Los Angeles (UCLA) Score
- Constant-Murley Score (CMS) Operative Procedures
The protocol requires completion of the following assessments during Visit 2:
- Open wound evaluation of rotator cuff tear for classification as large or massive with measurement of the tear to confirm size and length
- Enrollment confirmed using WMT randomization scheme for patient assignments Post Operative Procedures
Protocol requires the following assessments to be completed during the 1 month (plus 15 days) -Visit 3; 3 month (plus 15 days)-Visit 4; 6 month (plus 30 days) -Visit 5 and 12 month (plus 30 days) -Visit 6:
- MRI - Only performed during the 6 month (plus 30 day)-Visit 5 and 12 month (plus 30 days) -Visit 6
- ASES Scale
- CMS
- UCLA Score End of Study
Protocol requires completion of the following assessments during 24 month (plus 30 days)-Visit 7:
- MRI
- ASES Scale
- CMS
- UCLA Score
- Completion of End of Study Evaluation Form by the Principal Investigator
4.7 Scientific validity of the study design: Address the strengths and weaknesses of the selected design. Specifically indicate why a particular design was selected.
(1 page maximum - adhere to page limitations) Strengths: Prospective Randomized Clinical Trial Weakness: While not a true weakness, this trial is not randomized in the regular way but is using the "Expertise Randomization" style where the surgeon chooses his particular expertise of surgical repair of the rotator cuff (mini-open or arthroscopic) and the patients are randomized within that group.
A telephone randomization scheme cannot be used so there will be envelopes available to the surgeon in the OR for the group.
- Conditions
- Rotator Cuff Tear
- Being tested
- Augmentation, Rotator Cuff Repair without augmentation
- Keywords
- rotator cuff, randomized clinical trial
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AugmentationDevice
Also called Wright Medical Technology Graft Jacket
Rotator Cuff Repair plus Graft Jacket
Rotator Cuff Repair without augmentationProcedure or surgery
Rotator Cuff Repair without augmentation
| Study group | Role | What they receive |
|---|---|---|
| Augmentation | Experimental | Rotator Cuff Repair augmented with the Graft Jacket Device Receives: Device: Augmentation |
| No Augmentation | Active comparator | Rotator Cuff RFepair Receives: Device: Augmentation; Procedure: Rotator Cuff Repair without augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
less or no recurrence of shoulder rotator cuff tear with the use of the tissue scaffold than with the standard use of surgical anchors and screws as measured by MRI results
each subject will be eligible for the study based on the Pre-operative results of the MRI as it relates to the size of the tissue tear. The subjects will be assigned to either the tissue scaffold material or the standard surgical suture or anchors. Then, the procedure to repair is determined by the investigator as an arthoscopic or open procedure. Pos-operative evalutions via MRI will be obtained throughout the study to evaluate the effectiveness of the surgical procedure and for the measurement of retear or not.
Measured: 2 years
Secondary outcomes (4)
Scale (pain, ADL, Shoulder stability)
A baseline evaluation for pain scale, activity of daily living measurement and range of motion to determine injured and repaired shoulder stability
Measured: 2 years
UCLA Shoulder Score (pain, function, manual muscle testing)
Pain, function, manual muscle testing measured per UCLA Shoulder Score at baseline and at intervals at up to two years.
Measured: 2 years
Constant-Murley Shoulder Score (pain, function, ROM, Strength)
Pain, function, ROM, and Strength measured per Constant-Murley Shoulder Score at baseline and at intervals at up to two years.
Measured: 2 years
Surgeon Reported Satisfaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston, Southern California Orthopedic Institute Medical Group, Kelsey-Seybold Clinic, Plano Orthopedic & Sports Medicine Center, St Joseph's Hospital Hand & Upper Limb Center, Fowler Kennedy Sport Medicine Clinic, St. Boniface Hospital
- Responsible party
- Principal investigator, Robert Litchfield, MD, FRCSC, Fowler Kennedy Sport Medicine Clinic
- Investigators
- Robert Litchfield, MD, FRCSC, Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456781
- Sponsor's protocol ID
- Wright1
- Status last verified
- Jul 2014
- First submitted
- 21 Feb 2007
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GraftJacket® Rotator Cuff Tendon Reinforcement Scaffold: A Randomized Prospective Clinical Evaluation
- ClinicalTrials.gov ID
- NCT00456781
- Acronym / sponsor ID
- Wright1
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston, Southern California Orthopedic Institute Medical Group, Kelsey-Seybold Clinic, Plano Orthopedic & Sports Medicine Center, St Joseph's Hospital Hand & Upper Limb Center, Fowler Kennedy Sport Medicine Clinic, St. Boniface Hospital
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpose of this study is to determine whether rotator cuff repair augmentation using GraftJacket allograft provides a viable alternative, based on observed clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The study will secondarily investigate the difference in outcomes in patients treated arthroscopically versus open. This study will report patient progress and results at early (6 month) and late (2 year) time points in patients treated for large and massive reparable rotator cuff tears (>3cm). A reparable tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and re-tear rate will be included in the study evaluations.
Detailed description
This is a prospective multi-center clinical study evaluating GraftJacket in the augmentation of large and massive rotator cuff tears compared to the traditional surgical technique of sutures and anchors alone. The study group will consist of 160 patients (early withdrawals or drop outs will not be replaced). Surgical approach for each patient will be either mini-open or arthroscopic. Safety assessments for this clinical study will be based on reported adverse events. Any adverse event that occurs during the study that represents a change from the patient's condition as noted at baseline [determined by normal standard of care] that is related to the procedure will be documented by completing the adverse events case report form.
Each investigator will indicate which operative technique (mini-open or arthroscopic) will be used during the study period at their site. The site selection process will be used to attempt to attain an equal distribution of both operative techniques used in the study. Patients will be randomly assigned to the treatment groups A or B. A randomization scheme using a 2 block model will be used within each surgical technique. Randomization cards meeting the requirements for this process will be generated by the statistician. Both surgical technique treatment groups will use the same assessments for comparisons throughout the study period.
Enrollment Plan for the GraftJacket Rotator Cuff Tendon Reinforcement Scaffold Surgical Technique Open Surgical (suture and anchor) Arthroscopic Group A without augmentation Group B with GraftJacket Group A without augmentation Group B with GraftJacket
Patients with reparable rotator cuff repairs must present with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery to be eligible for enrollment. A reparable rotator cuff tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. It should be possible to accomplish a watertight repair or only leave a residual defect of less than or equal to 1cm. The anteroposterior and mediolateral dimensions of the rotator cuff tear will be assessed intra-operatively by measurements either including the edges or after the edges are trimmed depending on the judgment of the surgeon. Rotator cuff tears involving the subscapularis tendon will not be included in the study, because the postoperative rehabilitation is more difficult and may confound the outcome results of either group. Surgical variables that should be documented on source documents and appropriate CRFs are the size of rotator cuff tear, the number of tendons involved, the type of repair (open, mini-open, arthroscopic) and the type and number of sutures and anchors.
Both clinical assessments and magnetic resonance imaging will be used to evaluate the effectiveness of the surgical techniques in both groups A and B. A screen/baseline MRI will be obtained of the affected shoulder during the preoperative visit. This MRI will be used to evaluate the extent of involvement and determine suitability for enrollment into the study including the size of the tear and extent of muscle atrophy. Images obtained within 3 months of signing consent may be used to assess eligibility for enrollment. Three additional follow-up MRIs of the affected shoulder will be obtained as part of the 2 year post-operative evaluation and will be used to evaluate structural success of group A, suture and anchor or group B, GraftJacket® allograft augmentation. The MRI scans performed at 6 months, 12 months and 24 months will be used to determine the rate of re-tear and to help to assess the integrity of the rotator cuff. Re-tears which are evident on the 6-month MRI will be considered a failure of the surgical technique, will be excluded from further follow-up within the study and followed separately. The comparison of the proportions of re-tears in patients in groups A and B who complete the MRI regimen through 2 years will be used to determine if GraftJacket® augmentation is a viable alternative to suture and anchor.
The Investigator will use clinical, functional, radiological, assessment of adverse events and assessment of the surgical techniques of groups A or B to evaluate each patient enrolled in this clinical study.
Pre Operative Procedures - Screen (Baseline)
Screening activities are performed during Visit 1. The protocol requires the following assessments during that visit:
- Informed consent process completed before any study related activities begin
- Inclusion/Exclusion criteria evaluation for study entry qualifications
- Magnetic Resonance Imaging (MRI)
- American Shoulder and Elbow Society (ASES) Scale
- University California Los Angeles (UCLA) Score
- Constant-Murley Score (CMS) Operative Procedures
The protocol requires completion of the following assessments during Visit 2:
- Open wound evaluation of rotator cuff tear for classification as large or massive with measurement of the tear to confirm size and length
- Enrollment confirmed using WMT randomization scheme for patient assignments Post Operative Procedures
Protocol requires the following assessments to be completed during the 1 month (plus 15 days) -Visit 3; 3 month (plus 15 days)-Visit 4; 6 month (plus 30 days) -Visit 5 and 12 month (plus 30 days) -Visit 6:
- MRI - Only performed during the 6 month (plus 30 day)-Visit 5 and 12 month (plus 30 days) -Visit 6
- ASES Scale
- CMS
- UCLA Score End of Study
Protocol requires completion of the following assessments during 24 month (plus 30 days)-Visit 7:
- MRI
- ASES Scale
- CMS
- UCLA Score
- Completion of End of Study Evaluation Form by the Principal Investigator
4.7 Scientific validity of the study design: Address the strengths and weaknesses of the selected design. Specifically indicate why a particular design was selected.
(1 page maximum - adhere to page limitations) Strengths: Prospective Randomized Clinical Trial Weakness: While not a true weakness, this trial is not randomized in the regular way but is using the "Expertise Randomization" style where the surgeon chooses his particular expertise of surgical repair of the rotator cuff (mini-open or arthroscopic) and the patients are randomized within that group.
A telephone randomization scheme cannot be used so there will be envelopes available to the surgeon in the OR for the group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmentation | Experimental | Device: AugmentationRotator Cuff Repair augmented with the Graft Jacket Device |
| No Augmentation | Active comparator | Device: Augmentation, Procedure: Rotator Cuff Repair without augmentationRotator Cuff RFepair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between the ages of 18 - 75 years inclusive,
- Reads, understand and able to complete the patient reported outcomes in English,
- Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
- Patients with either primary or revision rotator cuff tears measuring < 5cm with at least 2 tendon involvement as indicated by MRI,
- Patients who have a reasonable movement of the non-operative arm, defined as a shoulder elevation of equal or more than 90°, and are able to perform (postoperative) exercises,
Key exclusion criteria (8 listed)
- Patients with irreparable large or massive rotator cuff tears <3cm will be excluded if found intra-operatively
- Patients with rotator cuff tears where the subscapularis tendon is disrupted,
- Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
- Patients with evidence of active infection, cancer, or highly communicable diseases that would preclude the patient from completing required patient assessments and clinic visits as described in the protocol,
- Patients who smoke,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AugmentationAlso: Wright Medical Technology Graft JacketRotator Cuff Repair plus Graft Jacket | Device | Augmentation, No Augmentation |
| Rotator Cuff Repair without augmentationRotator Cuff Repair without augmentation | Procedure or surgery | No Augmentation |
Primary outcome
less or no recurrence of shoulder rotator cuff tear with the use of the tissue scaffold than with the standard use of surgical anchors and screws as measured by MRI results
Time frame: 2 years
each subject will be eligible for the study based on the Pre-operative results of the MRI as it relates to the size of the tissue tear. The subjects will be assigned to either the tissue scaffold material or the standard surgical suture or anchors. Then, the procedure to repair is determined by the investigator as an arthoscopic or open procedure. Pos-operative evalutions via MRI will be obtained throughout the study to evaluate the effectiveness of the surgical procedure and for the measurement of retear or not.
4 secondary outcomes
Scale (pain, ADL, Shoulder stability)
Time frame: 2 years
UCLA Shoulder Score (pain, function, manual muscle testing)
Time frame: 2 years
Constant-Murley Shoulder Score (pain, function, ROM, Strength)
Time frame: 2 years
Surgeon Reported Satisfaction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Litchfield, MD, FRCSC principal investigator
Fowler Kennedy Sport Medicine Clinic
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentation and Rotator Cuff Repair without augmentation in people with Rotator Cuff Tear, run by Stryker Trauma and Extremities at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
less or no recurrence of shoulder rotator cuff tear with the use of the tissue scaffold than with the standard use of surgical anchors and screws as measured by MRI results (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.