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Thumb Metacarpophalangeal Hyperextension in an Arthritic Population; Part 2

Study Purpose

This is the second phase of a clinical study to assess MP hyperextension in CMC arthritis. In the first phase, submitted for publication, the investigators demonstrated that there is poor correlation between dynamic control of the MP joint and the amount of passive hyperextension preoperatively in a sample of patients with CMC arthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - • Adults (18 years of age or older) - Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis.
  • - Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays.
  • - Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study.
  • - Patients with greater than 20 degrees of passive MP Hyperextension.
o Screened by surgeons upon first evaluation in clinic.
  • - Bilateral thumbs included.

Exclusion Criteria:

  • - • <18 years age.
  • - Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb MP or CMC joints.
  • - Prior ipsilateral 1st ray deformity or malunion, distal radial malunion or nonunion, 2nd ray amputation or deformity.
  • - Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy.
  • - Inflammatory arthritis.
  • - Post-traumatic CMC arthritis.
  • - Prior trauma to the MP or CMC joints.
  • - Diagnosis of Ehler-Danlos syndrome or other connective tissue disorder.
- Concomitant treatment of the MP joint

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05835830
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Indiana Hand to Shoulder Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 CMC Arthritis
Additional Details

To date, no studies have looked at the relationship of preoperative and postoperative MP pinch position and passive MP hyperextension in an arthritic patient population. Other research has found that dynamic thumb MP pinch position is independent of passive MP hyperextension in a healthy non-arthritic population (thumbs with passive MP hyperextension on exam did not pinch in a position of MP hyperextension), but no such investigation has been performed in an arthritic population pre and postoperatively. It is also undetermined which of these parameters (dynamic pinch or passive MP hyperextension) has a larger correlation to postoperative outcomes following basilar joint arthroplasty, and which parameter should be considered when determining whether or not to surgically stabilize the MP joint at the time of CMC arthroplasty. The specific aim of this study is to compare the preoperative and postoperative changes in dynamic and passive range of motion of the thumb MP joint in patients undergoing CMC basilar joint reconstruction without concomitant MP joint stabilization. Secondary aims of this study will be to compare postoperative pinch and grasp strength, radiographic subsidence and longitudinal collapse, in addition to postoperative patient reported outcomes in patients with good dynamic MP control (<5 degrees) vs.#46;poor dynamic control (>5degrees) The hypothesis is that dynamic thumb MP pinch position will not change compared with its preoperative status. Investigators also hypothesize that patients with better dynamic pinch position postoperatively will have better pinch strength and better functional outcomes than patients with poor dynamic pinch position.

Contact a Trial Team

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Indiana Hand to Shoulder Center, Indianapolis, Indiana

Status

Address

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260

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