Health TrialsbyHealthPanel

Study Comparing SBS and LRTI for Treatment of CMC Arthritis

ConditionArthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorFraser Orthopaedic Research Society

About this trial

A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age fifty years or older

Isolated carpometacarpal (trapeziometacarpal) osteoarthritis

Failure to respond to non-operative management

Willing and able to consent on their own behalf and follow the protocol and clinical visits as described

Disqualifiers

Previous surgery for CMC arthritis

Duration of symptoms for less than 6 months

Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension

Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis

Trial design

Design model

Sequential

Treatments tested in this trial

  • CMC Arthroplasty

    Procedure/Surgery

    Surgical intervention to treat CMC arthritis

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Trapezial excision with or without soft tissue interposition and /or ligament reconstructionOther 1 intervention
Group B: Suture button suspension arthroplasty (SBS)Other 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale- Pain

Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale

Time frame
12 Months
2

Disabilities of the Arm, Shoulder and Hand Questionnaire

A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.

Time frame
12 Months
3

Patient Related Wrist Evaluation Questionnaire

A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living

Time frame
12 Months

Secondary outcomes

1

Operative Time

Time as recorded from the surgeons start of the procedure until the surgeons stop.

Time frame
Intraoperative
2

Strength

Transverse volar grip strength as measured by a dynamometer and key and lateral pinch strength measure by a pinch gauge

Time frame
12 Months
3

Range of Motion

Thumb flexion will be measured from the top of the thumb (pulp) to the base of the 5th metacarpal (pinky finger). Retropulsion measured as the distance between the thumb and table when the dorsum of the hand is pressed against the table.

Time frame
12 Months
4

Work Productivity and Activity Impairment: Specific Health Problem Questionnaire

A questionnaire pertaining to the effect of the participant's CMC arthritis on their ability to work and perform regular activities. Lower scores will indicate better outcomes.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fraser Orthopaedic Research Society

Lead sponsor

Source ClinicalTrials.gov
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