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Osteoarthritis clinical trials

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NCT ID: NCT02272218 Completed - Knee Osteoarthritis Clinical Trials

Bariatric Lap Band Surgery as a Treatment for Knee Osteoarthritis

Start date: October 23, 2012
Phase: N/A
Study type: Interventional

The primary purpose of this study is to evaluate laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical treatment. The primary outcome will be the reduction in OA-related pain and disability after LAGB.

NCT ID: NCT02269254 Completed - Clinical trials for Musculoskeletal Diseases

Persona Versus NexGen

Start date: September 2014
Phase: N/A
Study type: Interventional

The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet. The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis. Different sample sizes are used for the different parts of this study: - 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA - 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period. Main study parameters/endpoints are: - Migration, measured by means of RSA. - Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. - In vivo kinematics by means of fluoroscopy. - Patient Reported Outcome Measures by means of questionaires.

NCT ID: NCT02267044 Completed - Clinical trials for Primary Osteoarthritis, Unspecified Shoulder

Effective Pain Management of Interscalene Blocks During Shoulder Surgery

Start date: August 2014
Phase: N/A
Study type: Interventional

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient. Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

NCT ID: NCT02265523 Completed - Osteoarthritis Clinical Trials

Exercise and Cycle Ergometry Post TKA - A Randomized Controlled Trial

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this investigation is to examine the effect of, and improve patient compliance and motivation following total knee arthroplasty; to determine the efficacy of two post-surgical exercise programs on knee pain, function, range of motion, strength, and swelling (girth); and to establish a panel of biomarkers that will allow: a) early identification of patients at risk (i.e. unable to complete post-operative treatment) and; b) predict the likelihood of a successful treatment outcome post-surgically.

NCT ID: NCT02262364 Completed - Clinical trials for Osteoarthritis, Knee

Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)

Start date: November 2014
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety of a single injection of APS.

NCT ID: NCT02261038 Completed - Osteoarthritis Clinical Trials

Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT

Start date: November 2014
Phase: N/A
Study type: Interventional

Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform. Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images. It was the hypothesis that measurements on radiographs are comparable to measurement on CT images. Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.

NCT ID: NCT02260921 Completed - Knee Osteoarthritis Clinical Trials

Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain

Start date: October 20, 2014
Phase: N/A
Study type: Interventional

This purpose of this study is to evaluate the effectiveness and safety of the iovera° device for the temporary reduction of pain associated with knee osteoarthritis.

NCT ID: NCT02256098 Completed - Clinical trials for Musculoskeletal Diseases

RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA

APKnee
Start date: September 2014
Phase: N/A
Study type: Interventional

The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009). The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date (March 2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and positive feedback was received regarding patient recovery, stability and motion. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective of this study is to compare clinical and radiological outcome and PROMS of the prostheses with migration data. This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC Sigma Knee System will be included in this study. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: - Migration of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). - Patient Reported Outcome Measures by means of questionnaires.

NCT ID: NCT02253966 Completed - Hyperalgesia Clinical Trials

Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.

NCT ID: NCT02252939 Completed - Clinical trials for Trapeziometacarpal Arthrosis

Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

Start date: September 2013
Phase: N/A
Study type: Interventional

The investigators are doing this research study to discover factors, such as job, hobbies, or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis is one of the most common kinds of arthritis. About 116 people will take part in this research study at Massachusetts General Hospital (MGH).