Protein Turnover in the Osteoarthritic Knee

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. 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 preoperative protein supplementation on protein synthesis in different musculoskeletal tissues of the knee.

Objective: To investigate the effect of preoperative protein supplementation on Hoffa's fat pad, synovium, tendon, bone, muscle, ligament, menisci, and cartilage protein synthesis of the OA knee.

Study design: Randomized, parallel (two groups) study design. The intervention group will be compared to the control group.

Study population: 24 adults with OA of the knee undergoing TKR. Intervention: 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. Muscle biopsies and tissue collection will be performed during the surgical procedure.

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Key information

Conditions

Osteo Arthritis Knee Protein Metabolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent
Male and female patients scheduled for total knee arthroplasty
BMI between 18.5-30 kg/m2
Age > 18 years
Mentally competent, as judged by the treating physician
Functioning gastrointestinal tract, eligible for oral protein supplementation

Exclusion criteria

Corticosteroid injections less than 3 months prior to participation
Any medications know to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
Lactose intolerance
Insulin-dependent diabetes mellitus
Alcohol abuse
Rheumatoid arthritis
Peripheral artery disease Fontaine III or IV
COPD GOLD III or IV
Phenylketonuria
Surgical intervention in the past four weeks
Total parenteral nutrition at day of surgery
Neoadjuvant chemotherapy or radiotherapy
GFR <20 mL/min/1.73 m2
Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, OD, or malignant processes
Collagen disorders, e.g. Marfan and Ehler-Danlos
Any other medical condition that may interfere with the safety of the subjects or the outcome parameters, in the investigators judgement
Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol instructions
Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Treatment and study plan

Preoperative protein supplementation

Dietary Supplement

Daily 40 g of pre-sleep protein supplementation during 2-week preoperative period.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Protein Turnover in the Osteoarthritic Knee; the Impact of Preoperative Protein Intake and Intra-articular Corticosteroid Injections

Acronym: KneeT

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Jan 31, 2017
Registry last updated: Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed