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The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis;
It is hypothesized that thumb basal joint arthroplasty with metacarpal stabilization, by either ligament reconstruction (I) or suture suspension (II), provides greater improvement in grip and pinch strength, and better hand function, than might be achieved following provision of pain relief alone by simple trapeziectomy (III). Preservation of the arthroplasty space will correlate positively, and MCPJ hyperextension will correlate negatively, with improved thumb function and lateral pinch strength.
Primary Aims (within 3 procedure cohorts):
Secondary Aims (between 3 procedure cohorts):
Study Procedures: Upon obtaining informed consent and within 4 weeks of the planned date of surgery, each site coordinator will collect baseline clinical and demographic information, a visual analogue score (VAS), the Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Survey, the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and grip and then pinch measurements from the participant. On the same day, and immediately following collection of baseline clinical data in the clinic, the surgeon will anesthetize the trapeziometacarpal joint. Adequacy of the injection and resulting anesthesia of the joint will be assessed by repeat of the VAS score. Following 15 minutes set time for the local anesthetic, the VAS diagram will again be completed by the patient followed by recording of repeat grip and then pinch measurements. Each patient will then undergo one of three pre-specified procedures; trapeziectomy with ligament reconstruction-tendon interposition (LRTI) arthroplasty with flexor carpi radialis tendon; trapeziectomy with suture suspensionplasty; or arthroscopic trapeziectomy with temporary K-wire fixation. Patient follow-up visits are otherwise scheduled according to the surgeon's routine and by clinical indication only. The patient will follow the routine postoperative rehabilitation protocol and hand therapy program of the operating surgeon. Protective splinting and exercise programs are to be utilized per surgeon protocol and preference.Postoperative study assessment will occur at three and six months after operation, The 3 and 6 month evaluation will include PROMIS-10 and QuickDASH surveys, completion of the VAS pain diagram, and recording of grip, key, and pulp to pulp pinch strengths. Additionally, specific notation of paresthesias, dysaesthesias, or sensitivity of the incision will be made by the surgeon or hand therapist at the 3 and 6 month assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligament Reconstruction - Tendon Interposition (LRTI) | Patients undergoing thumb basal joint arthroplasty using LRTI procedure as treatment of osteoarthritis. |
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| Suture Suspensionplasty (SS) | Patients undergoing thumb basal joint arthroplasty using suture suspensionplasty (SS) procedure as treatment of osteoarthritis. |
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| Arthroscopic Trapeziectomy (AT) | Patients undergoing thumb basal joint arthroplasty using arthroscopic trapeziectomy (AT) procedure as treatment of osteoarthritis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trapeziectomy with ligament reconstruction (I; LRTI) | Procedure | Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in pre-operative pinch and grip strength as measured by kilograms of pressure within and between procedure cohorts before and after lidocaine injection of the trapeziometacarpal joint. | Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing. | Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery |
| Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain within and between procedure cohorts. | The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face). | Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery |
| Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts. | The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability). | Baseline, 3 months and 6 months after surgery |
| Change in Quality of Life as measured by the PROMIS-10 Global Health questionnaire, within and between procedure cohorts. | The PROMIS-10 Global Health measures five domains: physical function, fatigue, pain, emotional distress, and social health. Items are rated on a five-point scale. A higher score indicates better health. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications between procedure cohorts | Postoperative complications specifically related to superficial sensory neuritis or complex regional pain syndrome and wound related infection, between arthroplasty groups. | 3 months and 6 months post surgery |
| Change in absolute dynamic arthroplasty space height as measured by on a stress radiograph within and between procedure and cohorts |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients seen at participating centers who have failed non-operative treatment and are considering primary basal joint arthroplasty for a diagnosis of thumb basal joint osteoarthritis, post-traumatic arthritis, or have undergone a prior basal joint procedure for either fracture or instability resulting in persistent synovitis and are bothered by persistent symptoms, will be considered for participation in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent D Pellegrini, MD | Contact | (603) 650-5133 | Vincent.D.Pellegrini.Jr@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| Vincent D Pellegrini, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Trapeziectomy with suture suspensionplasty (II; SS) | Procedure | Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS) |
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| Arthroscopic Trapeziectomy (III; AT) | Procedure | Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT) |
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| Baseline, 3 months and 6 months after surgery |
The static and dynamic arthroplasty space will be comparatively assessed on immediate postop and sequential radiographs taken upon removal of plaster immobilization and K-wire fixation at 1 month, and at 3 and 6 months after surgery. Three and six month radiographs will be taken in Roberts anteroposterior (AP) and true lateral projections during lateral key pinch. The absolute arthroplasty space height, and its change over time following operation and plaster removal, will be correlated with improvement in strength. |
| Baseline, immediately after surgery, 1 month after surgery, 3 months and 6 months after surgery |
| Change in dynamic metacarpophalangeal joint position (MCPJ) and laxity as measured by hand goniometer within and between procedure cohorts | Dynamic position of the MCPJ will be measured with a hand goniometer during lateral pinch testing | Preoperative baseline, both before and after basal joint lidocaine injection, and then 3 months and 6 months after surgery |