Clinical Research Directory

TOUCH® CMC 1 New Enrollment US Study

The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.

Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis

A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis

Post Market Clinical Follow-Up TOUCH® CMC 1

Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA. The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck). The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force. Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.

Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone

In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.

Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints

The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid.

A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.

This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.

Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)

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.

Thumb Osteoarthritis Prognosis for Supported Self-managment

Background Thumb base osteoarthritis (OA) is common in adults 40 years and over. It affects a person's ability to work, be independent and care for others. Sufferers complain of severe pain and difficulty in completing everyday tasks. The main treatment for the condition is advice on how a person can manage their condition (self-management), reduce their pain, strengthen their hands with exercises and practical tips on tackling painful tasks, sometimes providing a hand splint for support. The treatment is provided by occupational and physiotherapists. We know that this treatment helps suffers in the short term (up to three months). But the research was done in people with few other health problems and while self-management support helps provide pain relief for most people, there are some people who don't benefit. The aim of this research is to see how pain and other hand problems change over a period of six months after the start of treatment, to understand people's experience of care, and examine why some people improve, and some do not. Research Plan In patients receiving treatment for thumb base OA at four NHS sites, who are willing to take part, this research will: - 1. Record changes in symptoms and quality of life at three and six months from when treatment began in a postal questionnaire/survey. 2. Discuss the experience of care and people's beliefs about what makes treatment a success by interviewing a small group of patients. 3. Analyse patient characteristics, to see if it is possible to determine how they will respond to treatment. 4. Develop recommendations for improving care.

Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device

Arthrodesis of a distal interphalangeal joint of the finger (DIP) is mainly performed for a degenerated and painful joint. Various stabilization methods have been used to provide compression at the arthrodesis site such as pins, steel wires, compression screws, headless compression screws, bioresorbable implants and intramedullary staples. Although with complications such as implant fractures or dorsal cortical erosion, intramedullary arthrodesis staples provide reliable pain relief and a consistent fusion rate while inevitably scarring the finger pulp or nail dystrophy. The aim of this study is to evaluate the bone fusion time during an arthrodesis performed with the Kerifuse shape memory implant.

Embo Registry; National Registry for Artery Embolization

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).