Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 7:56 PM
Study NCT ID:
NCT01425034
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition: a Prospective, Randomized Multi-center Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LRTI
Brief Summary:
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
Detailed Description:
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
Hand therapists find the Diagnosis and Treatment Manual by the Hand Rehabilitation Center of Indiana to be the 'bible' of hand therapy. They advocate a more aggressive, earlier motion, protocol. At week 2, a forearm based thumb spica cast or splint is placed. At week 4 active and passive range of motion to the thumb and wrist is started including palmar and radial abduction, wrist flexion, extension, ulnar and radial deviation, and thumb circumduction, flexion, and extension. At week 6, gentle strengthening is begun with discontinuation of the splint.4
A less popular but frequently used book, Hand and Upper Extremity Rehabilitation, a practical guide, their chapter on Thumb CMC arthroplasty included a concise protocol similar to the Indiana protocol. At week 2, active and passive MCP and IP range of motion is started. At week 4, CMC abduction and extension, CMC opposition and wrist range of motion is started. At week 8, pinch and grip strength is stressed. There is no discussion about splinting. 5
Despite these published protocols, there have been no studies looking at which protocol is better. There have been no prospective, randomized trials comparing a conservative approach consisting of longer immobilization with a more aggressive approach advocating earlier motion and shorter splinting times.
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
Hand therapists find the Diagnosis and Treatment Manual by the Hand Rehabilitation Center of Indiana to be the 'bible' of hand therapy. They advocate a more aggressive, earlier motion, protocol. At week 2, a forearm based thumb spica cast or splint is placed. At week 4 active and passive range of motion to the thumb and wrist is started including palmar and radial abduction, wrist flexion, extension, ulnar and radial deviation, and thumb circumduction, flexion, and extension. At week 6, gentle strengthening is begun with discontinuation of the splint.4
A less popular but frequently used book, Hand and Upper Extremity Rehabilitation, a practical guide, their chapter on Thumb CMC arthroplasty included a concise protocol similar to the Indiana protocol. At week 2, active and passive MCP and IP range of motion is started. At week 4, CMC abduction and extension, CMC opposition and wrist range of motion is started. At week 8, pinch and grip strength is stressed. There is no discussion about splinting. 5
Despite these published protocols, there have been no studies looking at which protocol is better. There have been no prospective, randomized trials comparing a conservative approach consisting of longer immobilization with a more aggressive approach advocating earlier motion and shorter splinting times.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: