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Osteoarthrosis of the Carpometacarpal Joint of the ThumbLRTINCT01425034

Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition

A study testing casts for the thumb and Motion group in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
casts for the thumb and Motion group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteUnited States
Study dates
Sep 2011to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • h/o CRPS
  • RA
  • Revision LRTI

Trial locations and contacts

1 site in 1 country.

United States1 site
  • InterMountain Health Care-TOSH orthopedic center

    Murray, Utah, 84107

Other trials in United States

About this study

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

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

Read the 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.

Being tested
casts for the thumb, Motion group
Keywords
Cast, motion, thumb CMC arthritis, Collateral Ligament of Metacarpophalangeal Joint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • casts for the thumbOther

    Also called Cast group

    The 'Cast' group will be placed in a thumb spica short arm cast with the thumb IP joint free. They will be allowed digit, thumb IP and elbow range of motion.

  • Motion groupOther

    The 'Motion' group will be placed in a forearm based thumb spica splint with the thumb IP free. They will be allowed digit, thumb IP and elbow range of motion.

Study groups in NCT01425034
Study groupRoleWhat they receive
Cast groupActive comparatorThe 'Cast' group will be placed in a thumb spica short arm cast with the thumb IP joint free. They will be allowed digit, thumb IP and elbow range of motion.
Receives: Other: casts for the thumb
Motion groupActive comparatorThe 'Motion' group will be placed in a forearm based thumb spica splint with the thumb IP free. They will be allowed digit, thumb IP and elbow range of motion.
Receives: Other: Motion group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425034
Sponsor's protocol ID
49860
Acronym
LRTI
Status last verified
Aug 2019
First submitted
22 Aug 2011
Last updated
20 Aug 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing casts for the thumb and Motion group in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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