Musculoskeletal Studies

Unity Total Knee Replacement Using Two Different Surgical Techniques (1405938)

This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients’ ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture to Treat Cartilage Defects of the Knee (1409979)

A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee.

Increasing Mitochondrial Function on Skeletal Muscle Performance in Older Men (1608287)

As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail, by measuring how the muscles work and respond to exercise before and after taking the supplement. This will give us the basic information investigators would need to see if this is a useful idea.

PATH2: Platelet rich plasma in achilles tendon healing (1708475)

Achilles tendon rupture (ATR) is when a person tears the tendon (the Achilles tendon) connecting the calf muscle and heal bone. It is the most common tendon injury and lead to months of incapacity. With an average work absence of 63-108 days there are significant costs to society and to the NHS. Platelet rich plasma (PRP) may improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. This study investigates how good PRP is at treating ATR using disease-specific and patient important outcomes.

Knee replacement bandaging study (KReBS) (1709493)

Total knee replacement (TKR) surgery is a common procedure where the weight bearing surfaces of the knee joint are replaced with metal and plastic components to relieve pain and disability. The most common condition which leads to the need for a TKR is osteoarthritis (a type of arthritis where the surface of joints wears away, causing pain and stiffness). Swelling around the knee is commonly seen after a patient has had TKR surgery, and is thought to contribute to pain after surgery and slowing down the rehabilitation process. Inelastic compression bandages (tight-fitting bandages) are routinely used in the treatment of a range of conditions, including leg ulcers and lymphedema (a long-term condition that causes swelling in the body’s tissues).

Fixed Versus Adjustable Loop in ACL Reconstruction (1711539)

A Prospective, Randomised Study Investigating the Use of a Fixed Loop Versus an Adjustable Suspensory Loop in Anterior Cruciate Ligament Reconstruction – a Comparison of Clinical and Functional Outcome.

UK Infinity, Post-Market Clinical Follow-up Study (1610323)

Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System Number of Subjects 500 with 10 sites.

Evaluation of a care pathway for patients with long-term pain after knee replacement (1702379)

Participants are randomly allocated to receive treatment as usual or the STAR treatment pathway (with twice as many patients receiving the STAR treatment pathway). The STAR pathway involves a clinic appointment at 3 months after knee replacement with a healthcare professional to better understand the possible causes of pain after knee replacement. Patients are then be referred to see relevant health professionals for treatment as needed, such as physiotherapists, orthopaedic (bone) surgeons, GPs, and pain specialists.

Trial to Compare Femoral Nerve Block With Local Anaesthetic Injection for Post-operative Pain After Knee Replacement (1409982)

Pain after a knee replacement can impair recovery and use of the new knee. Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may also give good pain relief. The null hypothesis is that there is no difference in primary or secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for knee replacement.

KFORT:­ Knee Fix or Replacement Trial (1605254)

Approximately 5­7,000 elderly people break their distal femur (lower end of the thigh bone) each year in the UK and most will undergo surgical fixation to fix the bone pieces together. It is recognised that unsatisfactory outcomes are common for this patient group; the operation is challenging, as the bones are often fragile and broken into many pieces, and patients are often instructed to keep weight off their injured leg for a considerable time to enable bone healing. As many will be too frail or confused to use crutches, patients can potentially remain bed bound until the fracture heals. An alternative to fixing the fracture is to remove the broken bone section and replace this with a complex form of knee replacement – a distal femoral replacement. This type of surgery avoids the problem of fixing fragile bone parts and patients can start walking on their injured leg immediately. However there are risks of infection or the replacement becoming loose. Currently we do not know which treatment is best. 

The Outcomes in Ankle Replacement Study (OARS) (1609301)

OARS is a questionnaire-based PROMS (Patient Reported Outcome Measures) study designed to learn more about how well total ankle joint replacements perform in individual patients in a real world setting. The study will be asking patients to complete a questionnaire before their operation, 6 months after their operation and 12 months after their operation. The questionnaire will collect information on the patient’s perceptions of symptoms and their ability to do daily activities with regard to their ankle, complete a self-report of their health status, and any use of health services. Additional details on radiology and surgical management and outcomes will be obtained by first contacting surgeons directly by email asking for their consent to submit pre- and post-operative (typically 6 week and 6 month) x-rays. Permission will be requested from participants to access baseline and post-operative X-rays for the study.