跳至主要内容
临床试验/NCT01425034
NCT01425034已完成不适用

Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition: a Prospective, Randomized Multi-center Study

University of Utah2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
2
主要终点
compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI)

研究概览

简要总结

Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity treated by hand surgeons in our society. It can be a significant source of functional disability secondary to a painful, and often weak, grip. Once patients have failed treatment by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the next option is surgical management. Several surgical options are available depending on the severity of the disease. For the early stages of arthritis options include a ligament reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage procedures exist. These have included simple trapeziectomy, arthrodesis and implant arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament reconstruction tendon interposition

详细描述

Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity treated by hand surgeons in our society. It can be a significant source of functional disability secondary to a painful, and often weak, grip. Once patients have failed treatment by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the next option is surgical management. Several surgical options are available depending on the severity of the disease. For the early stages of arthritis options include a ligament reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage procedures exist. These have included simple trapeziectomy, arthrodesis and implant arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament reconstruction tendon interposition. During this procedure the arthritic trapezium is excised to remove arthritic joint surfaces, the anterior oblique ligament is reconstructed to restore thumb metacarpal stability and prevent axial shortening, and a fascial interposition is performed to reduce the likelihood of impingement between neighboring bones.

Postoperative rehabilitation and splinting protocols have varied widely between institutions. In fact, no studies have been published looking specifically at these protocols. Some institutions have taken a more conservative approach, having their patients immobilized by some means for up to twelve weeks with no motion for six weeks. Others advance their patients more quickly and start motion at four weeks with discontinuation of splinting at eight weeks.

There is one Cochrane Review on surgical treatment of trapeziometacarpal joint arthritis that compared seven surgical techniques. They looked at outcomes of pain, physical function, range of motion, global assessment, strength, CMC imaging and adverse effects. There was no mention of a therapy protocol.1

The Hand Clinics, a comprehensive, state-of-the-art review by experts in the field, provide current, practical information of the diagnosis and treatment of conditions affecting the hand and wrist. Each issue focuses on a single topic relevant to hand surgery practice. In the most recent arthritis issue, Clinics 26 (2010), Bodin et al. discussed many surgical techniques and alluded to therapy after eight weeks of casting but no specific protocol is defined. 2

A recent book publication by the American Society for Surgery of the Hand and the American Society of Hand Therapists include a chapter on arthritis incorporating rehabilitation interventions following soft tissue reconstruction of the CMC joint. They advocate a more conservative approach. Up to four weeks a forearm based thumb spica cast is utilized with thumb IP range of motion and edema control. At week 5 the patient is changed to a forearm based thumb spica splint with addition of active range of motion of the wrist and thumb MP and IP joints. CMC joint range of motion is started at week 6. At this point isometric strengthening to the wrist, thenar and first dorsal interosseous muscles is initiated. At week 10 patients begin light pinch and grip exercises. The splint is discontinued week 12.3

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
Single (Participant)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 40 years old with basal arthritis who failed conservative treatment
  • Patients receiving LRTI by one of three enrolled surgeons at the U or one of the two enrolled surgeons at Intermountain who consented to the study

排除标准

  • Patients undergoing more procedures in addition to the LRTI that may alter the postoperative course, not including CTR or thumb MCP capsulodesis, MP fusion, trigger finger release
  • Revision LRTI

结局指标

主要结局

compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI)

时间窗: 2 years

DASH, VAS for pain, VAS for satisfaction, pinch and grip strength, coordination test and range of motion (thumb opposition)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Hutchinson

M.D.

University of Utah

研究点 (2)

Loading locations...

相似试验

Postoperative Rehabilitation Following Trapeziectomy... | 临床试验