Active clinical trials for "Osteoarthritis"

In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support either practice. Each intervention is considered standard care. There exists little evidence, however, to prove the clinical and cost effectiveness of either management option. The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis. This will be examined using an appropriate patient base and long term assessments. The trial has a combined device/expertise based allocation depending on the local situation. Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR, randomisation and allocation can be based on "device" (UKR or TKR). The same surgeon will perform the operation for both arms of the study. For surgeons who hold a preference for one treatment over the other, an "expertise" based randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients recruited to the study from these sites will be randomised to one of the treatment options and treated by the appropriate surgeon. In such cases the patient is internally referred to the other surgeon's operating list. Patients will be recruited by their consultant knee surgeons in collaboration with the local research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the trial.

Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function. Shoulder implants commonly used are characterised by a humeral stem and complications related to the stem are not infrequent. These include: bone stock loss, intraoperative and postoperative break around the implant, malpositioning of the humeral component and difficult eradication of infections inside the bone around the implant. With the aim of reducing stem-related complications, a novel prosthesis characterised by a stem-less design has been developed. The objective of this study is therefore to explore how well people recover after shoulder replacement with this novel stem-less shoulder prosthesis. This will be assessed over 5 years in three different countries in Europe using patient completed questionnaires and clinical and radiographic assessments.

In the history of TKA several different types of prosthetic designs have been evolved in order to optimize knee function after total knee replacement. The most common difference between the prosthetic designs revolves around issues concerning the preservation of the cruciate ligaments. The most popular prostheses have been the posterior stabilized prosthesis (PS) in which both cruciate ligaments are resected and the posterior cruciate retaining prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these prosthetic designs have shown excellent clinical results in the literature. In the knee the role of the cruciate ligaments is to insure anterior/posterior stability, but studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms which control joint kinematics essential for accurate knee function. One could therefore imagine that a prosthetic design that preserves both cruciate ligaments would be superior to prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results and patient satisfaction. Only a few prosthetic designs, which preserve both cruciate ligaments, have been available to the market. However studies based on fluoroscopic assays and gait analysis has shown that this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee kinematics during activities of daily living after TKA. Studies, in which patients have received two different types of prosthesis in each knee, have also shown that bi-cruciate retaining TKA's is preferred, when compared to more constrained prosthetic designs. The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of the Vanguard TKA system, which has shown good clinical results in earlier studies. With the new Vanguard XP system both cruciate ligaments are preserved. In theory this should result in a more natural feeling of the knee because the stability and proprioceptive signals from both cruciate ligaments are preserved. In order to investigate the potential benefits of this new prosthetic design, the clinical and radiological results of knees receiving a Vanguard XP and Vanguard CR prostheses are compared. In this study we wish to investigate: If the use of the Vanguard XP prosthesis will influence the migration of the femur- and tibial components measured by Radiostereometric Analysis (RSA) when compared to the Vanguard CR prosthesis. If the use of the Vanguard XP prosthesis will result in increased participant knee function, satisfaction and quality of life when compared to the Vanguard CR prosthesis. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis, complication rates and revision rates when compared to the Vanguard CR prosthesis. This project is carried out as a randomized controlled double-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either a Vanguard XP or Vanguard CR prosthesis is compared.

The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments

This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.

Surgical management for osteoarthritis of the thumb is indicated when conservative measures have failed, and numerous techniques have been proposed. Distraction arthroplasty has been the gold standard due to lack of high quality evidence, which renders the benefits or harms of other techniques uncertain. The other treatment alternatives share at least partial excision of the trapezium, and include ligament reconstruction alone or with tendon interposition, allograft interposition arthroplasty, prosthetic implants and arthrodesis. A recent promising technique is the pillow technique, a type of interposition arthroplasty, which utilizes a fascia lata allograft as interposition material and stabilization with a K-wire. In view of the low quality evidence regarding the use of interposition material versus distraction arthroplasty alone, the investigators will compare the two methods in a prospective randomized study design. Hypothesis of the study is that interposition arthroplasty using the pillow technique yields better results in terms of functional improvement and grip strength when compared to the hematoma and distraction technique. The confirmation of the hypothesis is going to justify the use of the fascia lata in the procedure. On the contrary, if the pillow technique fails to yield clinically meaningful results, the recommendation of the hematoma and distraction technique will account for reducing the overall cost of the procedure, rendering the allograft redundant.

This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.

The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted. On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory. The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice. In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice. The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.

Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.

The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.