The Effect of a Biomechanical Footwear as a Non-invasive Alternative to Total Knee Replacement and as an Additional Rehabilitation Regimen Postoperatively
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- pain: Numerical Pain Rating Scale
研究概览
简要总结
Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA.
The main objectives of this study are:
- To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR).
- To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.
详细描述
Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Future projections of the prevalence of OA predict an increase in prevalence, mainly due to the aging of the population and obesity.
Total knee replacement (TKR) is the end-stage solution for patients with knee OA. The total annual cost of arthritis in the U.S. in 2013 reached over $300 billion. Expenditure is expected to grow significantly in response to the increase in prevalence and the projected number of TKRs.
Successful and beneficial non-invasive treatment options for knee OA are limited. More specifically, although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA.
The main objectives of this study are:
- To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for TKR.
- To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women
- •Between ages 45 and 80, inclusive
- •ACR clinical criteria for OA of the knee
- •Symptomatic uni- or bilateral OA of the knee for at least six months
- •Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2
- •At least a moderate NPRS pain score at baseline (≥5)
- •Score of 1-3 based on the American Society of Anesthesiologists Physical Status Classification System
- •Willing and able to read, comprehend, and sign the study informed consent form in English prior to study specific procedure
排除标准
- •Body Mass Index (BMI) > 40
- •History of an inflammatory rheumatic disease
- •Non-knee musculoskeletal pain that is more severe than the knee pain
- •Corticosteroids injections in the knees in the previous 6 weeks
- •Previous major surgery to the knee such as osteotomy, hemiprosthesis, unilateral total joint replacement excluding knee arthroscopy > 6 months
- •Patients with Geisinger Health Plan insurance for whom Apos is a covered treatment
- •Patients with a recent history (<3 months) of a mental health condition, such as depression or anxiety
- •Problems with balance (>2 unexplained falls within the last 12 months; experiencing regular dizziness that has caused a trip or fall; using a walking aid to get around such as a rollator, cane, walker)
研究组 & 干预措施
AposHealth
Following the initial consultation and calibration of the Apos device in the clinic, the patients will receive from his therapist a home-based treatment plan. This usually includes wearing the device for about 20 minutes with about 20% of weight-bearing (patient is instructed to wear the Apos and just be with the device and go about his/her daily routine). A gradual increase in usage time is prescribed reaching up to 60 min wear time with about 40% weight-bearing.
Patients are requested to return to follow-up (FU) appointments after 1, 3, 6, 9 and 12 months. In addition, patients will have a remote FU after 1-week to confirm they use AposHealth as advised. During the follow-up appointment, re-assessment of clinical outcomes and gait patterns are performed and the calibration of the Apos device is adjusted as needed. The treatment plan is adjusted, and patients are encouraged to continue to wear the device regularly at home.
干预措施: AposHealth (Device)
Total Knee Replacement (TKR)
Patients will undergo TKR according to Geisinger's policy, guidelines and care protocol.
The study baseline visit will occur 6 weeks postoperative for TKR groups.
干预措施: Total Knee Replacement (TKR) (Procedure)
Post TKR traditional physical therapy (PT) and AposHealth
Patients who have had a knee replacement and were assigned to the traditional PT+ AposHealth group will follow Geisinger post-operative rehab protocol and will also receive AposHealth and follow the rehabilitation protocol.
AposHealth will start six weeks post-op and will continue for 12 months. Patients will receive AposHealth similar to the non-invasive group, i.e., will have an initial evaluation (IE) and calibration of the Apos device, have a remote FU after one week from IE and in-clinic FUs at 1, 3 6, 9 and 12 months.
干预措施: AposHealth (Device)
Post TKR traditional physical therapy (PT) and AposHealth
Patients who have had a knee replacement and were assigned to the traditional PT+ AposHealth group will follow Geisinger post-operative rehab protocol and will also receive AposHealth and follow the rehabilitation protocol.
AposHealth will start six weeks post-op and will continue for 12 months. Patients will receive AposHealth similar to the non-invasive group, i.e., will have an initial evaluation (IE) and calibration of the Apos device, have a remote FU after one week from IE and in-clinic FUs at 1, 3 6, 9 and 12 months.
干预措施: Total Knee Replacement (TKR) (Procedure)
结局指标
主要结局
pain: Numerical Pain Rating Scale
时间窗: 12 months
score range: worst 0 - 10 best
次要结局
- Veterans RAND 12 Health Survey (VR-12) physical component score(3, 6, and 12 months)
- Koos Jr(3, 6, and 12 months)
- pain: Numerical Pain Rating Scale(3 and 6 months)
- Step length (left and right)(6 and 12 months)
- Single limb support (SLS): % gait cycle (left and right)(6 and 12 months)
- Symmetry index (SI) for single limb support (SLS)(6 and 12 months)
- Pain medication intake(3, 6, and 12 months)
- Gait velocity(6 and 12 months)
- Symmetry index (SI) for step length(6 and 12 months)
- Decay rate in AposTherapy group(12 months)
研究者
Michael Suk, MD, JD, MPH, MBA, FACS
Professor and Chair, Musculoskeletal Institute & Department of Orthopaedic Surgery
Geisinger Clinic