The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis;
1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength,
2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration o…
The purpose of this study is to evaluate the basis for three widely held fundamental tenets about surgical intervention for thumb basal joint arthritis;
1. Trapeziectomy with ligament reconstruction and metacarpal stabilization is associated with superior functional outcomes and strength,
2. Preservation of the arthroplasty space correlates with functional outcomes, pain relief, and restoration of strength after basal joint arthroplasty, and
3. Mitigation of metacarpophalangeal joint (MCPJ) hyperextension optimizes postoperative strength after basal joint arthroplasty, regardless of surgical technique.
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):
1. Compare pre-operative pinch and grip strength as well as patient-reported outcomes (PROs) for pain in patients before and after lidocaine injection of the trapeziometacarpal joint, prior to thumb basal joint arthroplasty;
2. Compare post-operative pinch and grip strength and PROs for pain and function at 3 and 6 months after thumb basal joint arthroplasty with pre-operative values before and after lidocaine injection;
3. Correlate preservation of dynamic arthroplasty space as measured on a stress radiograph with postoperative improvement in pinch and grip strength, and PROs for pain and function;
4. Correlate dynamic MCP joint position and laxity with change in strength and patient-reported pain and function to define optimal MCPJ position.
Secondary Aims (between 3 procedure cohorts):
1. Compare change in pre- and post-operative pinch and grip strength and PROs for pain and function between patients having basal joint arthroplasty with and without specific metacarpal stabilization;
2. Compare preservation of the dynamic arthroplasty space and improvement in strength and patient-reported pain and function between arthroplasty groups; and
3. Compare changes in pinch and grip strength and PROs for pain and function with dynamic MCPJ position between arthroplasty groups.
4. Compare postoperative neuritis and complications between surgical groups.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Males and females 21 years of age or older;
* Undergoing elective non-prosthetic, primary basal joint arthroplasty;
* Patient has necessary mental capacity to participate and comply with study protocol;
* Patient is willing and able to give informed consent; and
* Patient is w…
Inclusion Criteria:
* Males and females 21 years of age or older;
* Undergoing elective non-prosthetic, primary basal joint arthroplasty;
* Patient has necessary mental capacity to participate and comply with study protocol;
* Patient is willing and able to give informed consent; and
* Patient is willing to participate under the care of their chosen surgeon.
Exclusion Criteria:
* Patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosis, psoriatic arthritis, or other related inflammatory arthritis;
* Patients undergoing simultaneous bilateral hand procedures of any nature;
* Women who are pregnant or breastfeeding;
* Women of reproductive potential unless there is a negative urine pregnancy test on the day of surgery. Women of child bearing potential include those who are premenopausal who have not had a bilateral oophorectomy, hysterectomy or tubal ligation. Post-menopausal is defined as not having had a menstrual period for at least one calendar year.
* Vulnerable patient populations including prisoners and institutionalized individuals.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
