Protein Turnover in the Osteoarthritic Knee (KneeT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03037294|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : August 14, 2019
Rationale: Osteoarthritis (OA) of the knee is a common cause of pain and disability, especially in people over the age of 65. In the current health care system both conservative (e.g. intra-articular injections with corticosteroids) and surgical (total knee replacement, TKR) treatment are applied. Although frequently used, certain effects of these treatments on protein metabolism remain unclear. It is well known that maintenance of different tissues is determined by a dynamic balance between protein synthesis and breakdown rates, with temporary changes in either protein synthesis or breakdown allowing net protein accretion or loss. However, intra-articular injections with corticosteroids as a conservative treatment are thought to have several negative consequences thereby potentially affecting protein metabolism of different musculoskeletal tissues. In addition, though protein supplementation has shown to be an effective nutritional strategy in stimulating muscle protein synthesis, it remains unclear to what extent other musculoskeletal tissues are able to respond to dietary protein supplementation. Therefore, the current study assesses the impact of intra-articular corticosteroid injections and preoperative protein supplementation on protein synthesis in different musculoskeletal tissues of the knee.
Objective: To investigate the effect of preoperative protein supplementation and corticosteroid injections on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and cartilage protein synthesis of the OA knee.
Study design: Randomized, parallel (three groups) study design. Each of the two intervention groups will be compared to the control group separately.
Study population: 36 adults (45-75 y) with OA of the knee undergoing TKR. Intervention: Intra-articular injection of betamethasone (2ml; 4mg/ml) and bupivacaine (8ml; 5mg/ml) or daily 40 g of pre-sleep protein two weeks before TKR, or no intervention.
Main study parameters/endpoints: Primary study parameters include protein synthesis rates and enrichments of Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and cartilage. Secondary parameters include whole-body protein synthesis, breakdown, oxidation, and net balance.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks involved in participating in this study are minimal. There are no potential effects known for the ingestion of protein. The corticosteroid injection is standard care in conservative treatment of osteoarthritis. Risks are small and limited to the knee itself, such as cartilage degeneration or joint destruction. Muscle biopsies and tissue collection will be performed during the surgical procedure.
|Condition or disease||Intervention/treatment||Phase|
|Osteo Arthritis Knee Protein Metabolism||Dietary Supplement: Preoperative protein supplementation Drug: Preoperative intra-articular corticosteroid injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Protein Turnover in the Osteoarthritic Knee; the Impact of Preoperative Protein Intake and Intra-articular Corticosteroid Injections|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
No Intervention: Control group
Subjects in the control group will receive no intervention.
Experimental: Protein group
Subjects in the protein group will receive a daily 40 g pre-sleep protein supplement during the 2-week preoperative period.
Dietary Supplement: Preoperative protein supplementation
Daily 40 g of pre-sleep protein supplementation during 2-week preoperative period.
Experimental: Corticosteroid group
Subjects in the corticosteroid group will receive a single intra-articular corticosteroid injection in the affected knee on the first day of the 2-week preoperative period.
Drug: Preoperative intra-articular corticosteroid injection
Intra-articular injection of corticosteroid (combination of betamethasone and bupivacaine) 2 weeks before surgery.
- Change in tissue-specific protein synthesis rates [ Time Frame: Throughout the surgical procedure (stable isotope methodology) and during the 2-week preoperative period (D2O dosing methodology). ]Fractional synthetic rates calculated based on tissue-free, plasma, and protein-bound tracer enrichments using stable isotope methodology and D2O dosing methodology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037294
|Contact: Joey Smeets, MSc, MDemail@example.com|
|Maastricht University Medical Center||Recruiting|
|Maastricht, Netherlands, 6229ER|
|Contact: Joey Smeets, MSc, MD +31651363946 firstname.lastname@example.org|