Clinical Study to Analyze the Functional, Radiological, and Strength Results in Lateralized Models and Inverted Arthroplasty Medializations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.
研究概览
简要总结
To determine the functional outcomes, complications and muscle performance by isokinetic study of two reverse arthroplasty systems (one with medialized center of rotation and the other with lateralized center of rotation) in the treatment of rotator cuff arthropathies or irreparable cuff tears.
详细描述
This is an experimental, prospective, unblinded, randomized, comparative clinical trial between patients with two types of prosthetic implants (inverted arthroplasty with medialized center of rotation vs inverted arthroplasty with lateralized center of rotation). Those male or female patients who meet the inclusion criteria will be selected to form part of one of the two randomly distributed study groups. Sample size Based on studies with similar characteristics but where lateralization is not performed with the implant but with a bone graft would require a sample size of 34 patients (17 in each group) assuming 20% losses with a Type I error of 0. 05 and a statistical power of 80% to show a difference of 10 points on the Constant scale (the minimal clinically important difference on the Constant scale for reverse arthroplasty is described as 8 points in previous comparative studies so we consider the detection of a difference of 10 to be sufficient. The minimal clinically important difference for function and strength in patients undergoing reverse shoulder arthroplasty. The final N needed would be 42 patients (21 per group). A randomization of patients will be performed to assign them to one or the other study group, which will be carried out by an independent assistant, who will generate a random sequence that will be unknown to the investigators. Each patient will be given a sealed and numbered envelope to choose from, in which the randomized group in which he/she has been included will be determined. The study will be blinded for the patient and rehabilitator but not for the surgeon.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients will be randomized to assign them to one or another study group, which will be carried out by an independent assistant, who will generate a random sequence that will be unknown to the investigators. Each patient will be given a sealed and numbered envelope to choose from, in which the randomized group in which he/she has been included will be determined. The study will be blinded for the patient and rehabilitator but not for the surgeon
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients over 65 years of age with rotator cuff arthropathy refractory to conservative treatment after six months.
- •Ability to understand the information sheet, informed consent and evaluation scales.
排除标准
- •Patients with sequelae of fractures, rheumatoid arthritis, avascular necrosis, primary glenohumeral arthrosis, revision surgeries that have required conversion to a ATHI
- •Patients in whom another surgical procedure has been associated with ATHI such as a tendon transfer
- •Glenoid bone defects in the horizontal plane (Type B2 and C of the Walch classification) or in the vertical plane (E3 Sirveaux).
研究组 & 干预措施
patients operated by means of inverted shoulder prosthesis with lateralized component
patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a lateralized center of rotation.
干预措施: reverse shoulder arthroplasty (Procedure)
patients operated on by means of an inverted shoulder prosthesis with medialized component
patients meeting the inclusion criteria who underwent surgery for a rotator cuff tear using an inverted shoulder prosthesis with a medially rotated center of rotation.
干预措施: reverse shoulder arthroplasty (Procedure)
结局指标
主要结局
to compare functional outcomes in patients with cuff arthropathies treated with medialized ATHI or lateralized ATHI.
时间窗: 24 Months
To compare functional outcomes (Constant scale score) 24 months after surgery in patients over 65 years of age with cuff arthropathies treated with either of two options: Medialized ATHI or lateralized ATHI. the score ranges from 0-100 points. The higher the score the better the functional result
次要结局
- Comparison of the results of the visual analog pain scale (VAS)(24 Months)
- Comparison of Joint Range of Motion between the two prosthetic systems under study.(24 Months)
- Analysis and comparison of the Maximum recorded muscle force.(24 Months)
- Analysis and comparison of the Deceleration speed(24 Months)
- Analysis and comparison of the isokinetic parameters (Agonist/antagonist ratio)(24 Months)
- Comparison of the results of the American Shoulder and Elbow Surgeons score(24 Months)
- Analysis and comparison of the Maximum strength as a function of weight(24 Months)
- Analysis and comparison of the Total work per repetition(24 Months)
- Analysis and comparison of the isokinetic parameter (Coefficient of variation )(24 Months)
- Analysis and comparison of the isokinetic parameters (Average power)(24 Months)
- Analysis and comparison of the Acceleration rate(24 Months)
- Determination and comparison of the prevalence of complications with each of the prosthetic systems.(24 Months)
- Comparison of the results of the Quick Disabilities of arm, shoulder and hand (Quick-DASH) score.(24 Months)
研究者
Yaiza Lopiz Morales
Principal Investigator
Hospital San Carlos, Madrid