Treatment Trials

17 Clinical Trials for Various Conditions

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COMPLETED
CMC Arthritis - Neoprene Vs. Thermoplast Short Opponens Splinting
Description

Carpometacarpal Thumb Arthritis is a disease caused by different factors and attacks mainly woman older than 50 years. The signs and symptoms consist in pain, swelling, joint instability, deformity and loss of motion. Some evidence has shown that splinting of the thumb may be of benefit. There are two methods of splinting: The first is Standard Neoprene wrap-on thumb support (in which the finger is kept in the same position with in a standard Neoprene thumb splint). The second is Thermoplast Short Opponens splint (This splint is custom-made and the thumb is use as a template to design the splint). The purpose of this study is to test and evaluate these two protocols of splinting and assess which one helps or works better in patients with thumb arthritis.

RECRUITING
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
Description

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty

RECRUITING
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
Description

The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.

COMPLETED
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
Description

Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist. We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.

WITHDRAWN
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Description

32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

Conditions
COMPLETED
Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
Description

Hypothesis: The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb. A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Using the concept of an implant acting as a spacer and stabilizer the investigators proposed and implemented a novel surgical technique using allograft knee meniscus as a biologic implant for the treatment of basal joint arthritis of the thumb.

Conditions
TERMINATED
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Description

Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.

COMPLETED
The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
Description

This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.

Conditions
COMPLETED
Use of FlexHD as Post Trapeziectomy Spacer
Description

The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.

ENROLLING_BY_INVITATION
Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis
Description

The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are: * Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug. * Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis? * Is Turmeric safe for participants with thumb-joint arthritis? Participants will: * take 4 weeks of daily Turmeric capsules, * take 4 weeks of daily placebo capsules * answer daily surveys about how they are feeling and functioning.

TERMINATED
Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
Description

Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.

COMPLETED
Mechanisms of a Dynamic Stability Approach
Description

Background. Arthritis is the leading cause of disability in the United States and osteoarthritis (OA) of the hand affects an estimated 25.6 US residents. OA of the thumb carpometacarpal (CMC) joint is the most disabling form of hand OA. Rehabilitation for persons with thumb CMC OA is recommended as the initial treatment and often involves instruction on joint protection and fitting of a splint to reduce joint stress and pain. More recently, evidence has suggested that specialized exercise may impact a factor linked to this condition, altered joint mechanics. Health records data also suggests that these exercises reduce pain and disability more than what would be experienced by those receiving standard care (SOC) rehabilitation. However, there has not yet been a prospective investigation on how these dynamic stability (DS) exercises alter joint mechanics, improve function, and reduce pain relative to standard treatment. Relatedly, thumb CMC mechanics are most often assessed by physicians through CAT scan and although rehabilitation therapists are not licensed to conduct such assessments, they could benefit from 'real-time' imaging to inform and evaluate the mechanical effects of treatment. Sonography might afford therapists the precision to evaluate mechanical response to treatment yet it is not yet known if thumb CMC sonography corresponds with the gold standard, CAT scan. Goal and Specific Aims. The long term goal this line of study is to reduce the effects of thumb CMC OA on activity performance and participation through non-invasive and non- pharmacological interventions. We expect to achieve our goals by pursuit of the following two specific aims: 1). Determine if a novel exercise regimen reduces radiographic thumb CMC joint misalignment among persons with thumb carpometacarpal osteoarthritis and 2) Evaluate the accuracy of ultrasound compared with CAT scan (reference standard) for quantifying thumb CMC subluxation Design and Methods. Specific aim 1 will be addressed through a prospective pre-post interventional study of a 8-week clinic-based dynamic stability program and will undergo a CAT scan before treatment and upon completion of the program (9 weeks) and specific aim 3 will be addressed through a psychometric 'concurrent validity' design.

COMPLETED
Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition
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

TERMINATED
Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
Description

Basal arthritis of the thumb is a common condition with increased prevalence in post-menopausal women, obese persons, and the elderly. Surgical options are varied and efficacious, but not all patients are candidates for surgery. The successes and pitfalls of previous, similar trials are carefully considered in the creation of our own. Though steroid injection is the standard of care in basal joint arthritis, current data does not support its efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal joint might be the next great tool in treating this common, debilitating disease.

SUSPENDED
Study on Basal Joint Arthritis Prospective
Description

The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.

ENROLLING_BY_INVITATION
Efficacy of a Single Injection of CTM for Post-Operative CMC Arthritis
Description

The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.

WITHDRAWN
Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
Description

The oval-8 splint has been developed for many uses in finger pathology and trauma. It has not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment option for non-operative management. Many studies have been performed showing that thumb spica splinting in abduction with either a hand based or forearm based splint improves pain. This study aims to compare the effects of a novel splinting approach with oval-8 splints for the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of patients with thumb CMC joint arthritis. This is a pilot study will address the following hypothesis: Splinting of the hyperextended thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on physical exam compared to splinting with thumb spica splints in patients with thumb CMC arthritis.