TWO-ARM, SINGLE BLIND, RANDOMIZED POST-MARKET STUDY ON THE USE OF HEALICOIL™ REGENESORB SUTURE ANCHOR IN THE REPAIR OF TEARS OF THE ROTATOR CUFF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Ossification Quality Score (Bony Ingrowth Assessed Via CT)
研究概览
简要总结
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 35 to 75 years at the time of surgery.
- •Willing and able to give voluntary informed consent to participate in this investigation.
- •Full thickness tear of the rotator cuff
- •Tear requires repair within one year of initial diagnosis.
- •Tear must be anatomically repairable (must be able to get tendon back to the medial position on the footprint and at least back to the tuberosity).
- •Willing and able, in the opinion of the Investigator, to cooperate with study procedures, and willing to return to study site for all required post-operative study visits.
排除标准
- •Evidence of acute trauma including fracture or dislocation of the shoulder joint.
- •Chronic retraction.
- •Evidence of active infection, osteomyelitis, sepsis or distant infection, which could spread to the index joint.
- •Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder.
- •Subject has had acromioplasty or diagnostic arthroscopy on the operative shoulder within one (1) year prior to scheduled surgery date.
- •Evidence of osteomalacia or other metabolic bone disorder(s), which may impair bone or soft tissue function.
- •Evidence of other significant shoulder pathology including (Type II-IV lesion, Bankart lesion, Hill Sachs lesion).
- •Patient has grade 4 changes to articular cartilage in operative shoulder
- •Inflammatory arthropathies.
- •Significant muscle paralysis of the shoulder girdle.
- •Painful pathologies of the cervical spine.
- •Comminuted bone surface, which would compromise secure anchor fixation.
- •Non-surgical rotator cuff associated treatment, such as corticosteroid injection, within one (1) month prior to scheduled surgery date.
- •Participating in another investigational trial or ongoing study that would interfere with the assessment of the primary and secondary outcomes.
- •Female patient who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
- •Major psychiatric illness, developmental handicap or inability to read and understand the English language.
- •Major medical illness that would preclude undergoing surgery.
- •Known to be involved in any active injury litigation claims relating to the study shoulder.
- •Unwilling or unable to be assessed according to study protocol for two years following surgery.
- •Patient requires a concomitant SLAP repair procedure in operative shoulder.
- •Surgeon plans to use a Platelet Rich Plasma product or another therapy intended to augment healing of the rotator cuff in the study procedure.
- •Protocol specified surgical technique cannot be followed for this subject.
- •Rotator cuff repair will be done via open (as opposed to arthroscopic) procedure.
- •Any other reason (in the judgment of the investigator).
结局指标
主要结局
Ossification Quality Score (Bony Ingrowth Assessed Via CT)
时间窗: 2 years
The ossification quality score is an ordinal measure of quality of bone reabsorption that is divided into four progressive groups. Quality score 1 reflects "little or no bone ossification", Quality score 2 reflects "Some ossification; discontinuous or with a wide lucent rim", Quality score 3 reflects "Ossification with a thin lucent rim", and Quality score 4 reflects "Good ossification; border of tract vague". For this study, Quality scores 1 and 2 will be merged (defined as low quality ossification) as will Quality scores 3 and 4 (defined as high quality ossification). The proportion of suture anchors graded as having high quality ossification versus low quality ossification will be compared between the two groups to determine if there is a significant difference between Healicoil and Twinfix anchors in regards to quality of ossification.
次要结局
- Number of Participants With a Rotator Cuff Re-tear(6 months)
- Function at Two Years as Measured by Western Ontario Rotator Cuff Index (WORC), PENN Shoulder Score (PENN), Single Assessment Numeric Evaluation (SANE), and EuroQol-5D (EQ-5D)(2 years)
- Visual Analogue Pain Scale(2 years)