Clinical data, statistics, and figures about the use of InSpace for arthroscopic treatment of massive, irreparable rotator cuff tears.
How was this US Pivotal Clinical Study done?
This study looked at the safety and effectiveness of the InSpace implant as compared to the standard of care, Partial Repair (PR) for patients with massive, irreparable, rotator cuff tears (MIRCT). The study included 184 patients across 20 different medical centers, who were randomly assigned (such as by flipping a coin) to one of two surgical treatment groups:
1) InSpace implant or
2) Partial Repair procedure using bone anchors
All study patients, regardless of the treatment group they were in, were given questions to assess their pain, strength, and shoulder function before and after surgery at scheduled follow-up visits. Study patients were not aware of which treatment they received until after the study was completed at two (2) years.
InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears
A Multicenter, Single-Blinded, Randomized Controlled TrialClick here to read
US Pivotal Clinical Study safety information1
A strong safety profile
Safety was measured by recording any mild to severe, common, or uncommon symptoms (called adverse events—AEs), as well as any serious symptoms thought to be due to the implant or anchor itself (called serious adverse device effects—SADEs). These were monitored for the length of the 2 year study.
Both InSpace and Partial Repair treatments were well tolerated by the study participants. However, AEs of the treated shoulder did occur in both treatment groups. Most were reported to be mild to moderate in severity, and the majority of events got better over the course of the study. The most common event reported was shoulder pain, and other types of events reported included stiffness, inflammation, and swelling. There were more AEs of the treated shoulder reported for InSpace subjects, and approximately one-third of InSpace patients and one-quarter of Partial Repair patients reported an event related to their treated shoulder. Please note that complications reported by InSpace and Partial Repair patients were reviewed by a group of experts in shoulder surgery, and it was determined that none were related to the treatment devices (i.e., the InSpace™ Implant or devices used for Partial Repair).
AEs for all other body parts, other than the shoulder, were also recorded. The most common types reported included musculoskeletal pain, falls and/or other soft tissue injuries, dizziness, headaches, and pain. There were more total AEs reported in the InSpace group, but similar numbers were observed between the two treatment groups for more serious symptoms in other parts of the body.
Safety results summary1:
- No patient experienced a Serious Adverse Device Effect (SADE) during the study.
- No InSpace implants required surgical removal.
- No adverse events were related to the InSpace implant, or the anchor implants used for patients in the partial repair group.
- Similar rates of additional surgery were observed during the entire study (InSpace group had 4 and Partial Repair group had 3).
- InSpace showed similar results for the two years of the study compared to partial repair.
US Pivotal Clinical Study effectiveness information
Functional results were measured through many patient and surgeon questionnaires with a score prior to surgery (also called ‘baseline’). These scores were then taken at every visit (7 in total) over the course of the 2-year study.
Both study patient groups completed three questionnaires designed to measure:
- Quality of life such as physical symptoms, sports and recreation, work, lifestyle, emotions (measured by the WORC score) and
- Pain, instability, activities of daily living, Range of Motion 'ROM', signs, and strength (measured by ASES and Constant scores)
The results of the study found InSpace to be effective for the subgroup of patients 65 years of age and older and showed:
Early functional recovery
Patient questionnaire scores showed early functional recovery at Week 6: ASES, ROM, and Constant scores4
- 77% and above of both InSpace and PR groups (all ages) showed improvement scores from before surgery (baseline)3
- InSpace patients showed either the same improvement scores (ASES) or better scores (WORC and CS) than the Partial Repair group at 6 weeks and other time points until 24 months1
Early return to range of motion
Results of Range of Motion scores at Week 6
- On average, InSpace group patients showed in increase in Range of Motion compared to Partial Repair group patients following surgery, as early as 6 weeks after surgery. 4
- Significant improvements were found at Day 10, Week 6, Month 12 and Month 24 for patients treated with InSpace as compared to those treated with a partial repair.
Shorter surgical times
Results of both InSpace and partial repair surgical times3:
- InSpace group showed shorter surgical times on average than Partial Repair group in all categories in the table below
|InSpace||Partial Repair||Time Difference|
|Duration of Operating Room Time (minutes)||84.3||113.1||28.8|
|Duration of Procedure Time (minutes)||44.6||71.2||26.6|
|Duration of Anesthesia Time (minutes)||91.4||121.1||29.7|
In conclusion, the InSpace implant was found to be effective for the subgroup of patients 65 years of age and older and showed similar results to partial repair, with notable benefits of early functional recovery, early return to range of motion and shorter operative time.
Interested in learning more about clinical trials with InSpace?
Select a current Stryker-sponsored study to learn more:IACCELERATE | NCT05329584
- Verma N, Srikumaran U, Roden CM, Rogusky EJ, Lapner P, Neill H, Abboud JA. (2022). InSpace implant compared with partial repair for treatment of full-thickness massive rotator cuff tears. J Bone Joint Surg Am. Advance online publication. doi. 10.2106/JBJS.21.00667.
- 1000903878 Rev. A Patient Education Brochure Stryker
- 1000903813 Rev. A Elevating Motion Stryker
- Brady, J.S., et al., Association of Anesthesia Duration With Complications After Microvascular Reconstruction of the Head and Neck. JAMA Facial Plast Surg, 2018. 20(3): p. 188-195
- Phan, K., et al., Anesthesia Duration as an Independent Risk Factor for Early Postoperative Complications in Adults Undergoing Elective ACDF. Global Spine J, 2017. 7(8): p. 727-734.
IMPORTANT INFORMATION ABOUT INSPACE
The InSpace Implant is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
The InSpace Implant is not appropriate for patients with certain types of infections, known or suspected allegories to the implant and/or instrument materials, or children.
The following information provided is based on data collected in the US Pivotal Clinical Study. There is evidence of increased risk of total adverse events of the affected shoulder compared to a partial rotator cuff repair, which were reported to be mostly mild to moderate in severity. Please note that complications reported by InSpace and Partial Repair patients were reviewed by a group of experts in shoulder surgery, and it was determined that none were related to the treatment devices (i.e., the InSpace Implant or devices used for Partial Repair). There is evidence of increased adverse events associated with a serious risk of the index shoulder which includes both medical and surgical treatments. The InSpace Implant is not fixed in place and may change position in the shoulder space. Movement out of the subacromial space and/or deflation of the InSpace Implant was observed in magnetic resonance imaging (MRI) 6 weeks post-operatively in up to half of patients. In these cases, it should be noted that no re-operations were required to remove the InSpace Implant.
The risks and benefits of the InSpace Implant in patients with the following conditions should be carefully considered: severe arthritis in the shoulder or full thickness cartilage loss, deltoid muscle defect or deltoid muscle paralysis, evidence that the shoulder is very unstable, missing or non-intact ligaments in the shoulder, known loss of sensation, major medical conditions such as blood clotting disorders, conditions that suppress the immune system or any other conditions that may compromise healing, safety and effectiveness of InSpace Implant use in patients below age sixty-five (65) has not been established, and safety and effectiveness of InSpace Implant use in pregnant or nursing mothers has not been evaluated.
If a reaction occurs, it will require follow-up with your surgeon. Some examples are as follows: irritation at the site where a cut was made during surgery, local infection, inflammation, and tissue damage where the InSpace Implant was implanted, or worsening of an existing infection. Additionally, movement of the implant out of its intended location may lead to worsening of your shoulder pain, discomfort, and/or stiffness which may require a re-operation, narcotic medications, non-narcotic pain medications, or post-operative shoulder injections.
As with any surgery, your surgical procedure may cause complications or adverse events. As with any shoulder surgery involving anesthesia there are potential risks and complications, including dizziness, fainting, difficulty breathing, wound infection, wound drainage, swelling, local pain, bleeding, bruising, surgical wound opening, nerve pain or injury which could result in partial or complete loss of movement in your affected arm, tendon injury, loss of sensation in your skin and muscle around your surgical site, inflammation of the tissues that surround your rotator cuff joint, a frozen rotator cuff (inability to freely move the shoulder joint) and delayed wound healing. There is a risk that a deep vein clot will form (thrombosis) and travel to the lung (pulmonary embolism), which could lead to stroke, heart damage or death. Any of the aforementioned complications/risks could require treatment such as medicine or additional surgery that may involve replacing or removing your InSpace Implant dependent on timeframe as the implant is biodegradable.
The information presented is for educational purposes only. Speak to your doctor to decide if you are interested in learning more about the InSpace Implant. Individual results vary and not all patients will receive the same postoperative activity level. It is important to follow your surgeon’s advice regarding after surgery care (for example, physical therapy) as well as which immediate activities you may or may not perform after receiving the InSpace Implant. Not following this advice may cause complications with the InSpace Implant. Some complications may require you to have additional surgery. Ask your doctor if the InSpace Implant is right for you.
Stryker Corporation or its other divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: InSpace, Stryker, Together with our customers, we are driven to make healthcare better. All other trademarks are trademarks of their respective owners or holders.
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