Clinical and Patient-reported Outcomes After Total Wrist Arthroplasty and Total Wrist Arthrodesis: A Prospective Cohort-study With 2-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 51
- 主要终点
- Patient-Rated Wrist Evaluation (PRWE) at 24 months
研究概览
简要总结
The wrist is often considered to be the fundament of the hand. Patients with a destroyed wrist joint caused by osteoarthritis or rheumatoid arthritis may suffer from pain and functional disabilities with impaired life quality.
The traditional surgical solution for advanced wrist arthritis is a total wrist fusion (TWF). Although TWF creates a stable wrist with minimal pain, the prize is the joint motion. Total wrist arthroplasty (TWA) is a motion-preserving alternative, but has failed to achieve the widespread use of other joint replacement procedures. TWA is more costly and technically demanding than TWF, and also associated with more complications. In addition, there is no consensus regarding the functional benefit of a TWA compared to TWF since prospective, comparative studies are missing.
Aim: The purpose of this prospective cohort study was to compare functional outcome and activity limitations up to two years after surgery with TWA or TWF.
详细描述
Patients with advanced wrist arthritis engaging both the midcarpal- and radiocarpal joints may suffer from pain, decreased joint motion and reduced grip strength. The traditional surgical solution with TWF creates a stable wrist with decreased pain, but the prize is the loss of wrist motion. TWA may be a motion-preserving alternative, but is more technically demanding and is associated with more complications compared to TWF. In addition, the functional benefits of TWA over TWF are still unknown.
Aim: The purpose of this prospective cohort study was to compare functional outcome and activity limitations up to two years after surgery with TWA or TWF.
Methods: In this single-center prospective, longitudinal cohort-study, all patients treated with TWF or TWA due to end-stage wrist arthritis at one hand surgical department between March 1, 2015, through February 28, 2020, were enrolled.The treatment method was decided by the treating consultant in hand surgery, based on clinical evaluation of the patient and radiographic appearance of the wrist, in combination with the patients' own requests and prerequisites.
Assessments were performed at baseline, 3 months, 6 months, 12 months and 24 months after surgery with patient-reported outcome measures, range-of-motion, grip strength and radiographic evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Both radoiocarpal and mid carpal arthritis due to osteoarthritis, inflammatory arthritis (such as rheumatoid/psoriasis arthritis), Kienböck's disease
排除标准
- •Wrist problems due to hypermobility or cerebral palsy
- •Severe cognitive disorder and unable to fill in questionnaires
结局指标
主要结局
Patient-Rated Wrist Evaluation (PRWE) at 24 months
时间窗: Up to 24 months
The PRWE is a self-reported questionnaire that includes 15 questions, divided into two subscales assessing pain (5 items) and function (10 items, 6 concerning specific tasks and 4 the ability to perform daily activities) over the past week. The questions are scored on a 10-point ordered categorical scale, ranging from no pain or no difficulty (0 points), to worst pain or unable to do (10 points). The total score of the subscales pain (sum of 5 items) and function (sum of 10 items divided by 2) ranges from 0 to 50. The maximum total score of PRWE is 100 and represents the worst disability, whereas 0 represents no disability.
次要结局
- Visual Analoge Scale (VAS) pain at rest and on load(Up to 24 months)
- Grip strength(Up to 24 months)
- Disability of the Hand, Shoulder and Arm (DASH)(Up to 24 months)