Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty

The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA).

The main question[s] it aims to answer are:

* Is KD non-inferior to KP regarding pain, function and stiffness (as indicated by the total score on the total Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC), with a non-inferiority limit of 15 points) at 2 years? * Is KD non-inferior to KP regarding Quality of Life (36-Item Short Form Health Survey, (SF36), Physical- and Mental- Component Summary (PCS/MCS), with a non-inferiority limit of 10 points) at 2 years? * Does KD lead to regeneration of tissue (increase in minimum joint-space-width > 0.05mm on x-ray) over 2 years?

Participants will be allocated to undergo either a knee joint distraction or prosthesis (total- or unicompartmental KP according to orthopedic surgeon/patients discretion), and groups will be compared using will be compared between groups using (multivariable) random effects (mixed) modelling to account for the nested and longitudinal structure of the data over the 24 months follow-up. The stratification factors for randomization, center (using a random intercept) and gender, as well as a limited number of a priori defined prognostic factors (i.e. baseline WOMAC total score, age, BMI, severity of cartilage damage) will be accounted for in this analysis. The difference in mean total WOMAC score at 24 months between treatment groups will be estimated from this model with a 95% confidence interval (CI) and non-inferiority will be determined using the lower limit of this confidence interval.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinical diagnosis of knee OA
Age ≤ 65 years and ≥ 18 years
Persistent, refractory pain, insufficiently responding to conservative or previous surgical therapy
Structural OA joint damage, indicated by a K&L grade of at least 2 as determined by the orthopedic surgeon in line with NOV recommendations.
Able to wear an external fixator and care for it for 6 weeks
Accepting that the maximal effect of KJD is not present directly after removal of the frame but may take months after frame removal
Sufficient joint stability (according to the orthopedic surgeon's judgement)
Flexion (>100 degrees) and extension range (<10 degrees)
Weight and BMI <120 kg and <35 kg/m2, respectively
Sufficient understanding of the Dutch language
Signed informed consent

Exclusion criteria

Surgical intervention in last 6 months
Leg-axis deviation > 10 degrees (as determined by the orthopedic surgeon)
Serious osteopenia making placing bone-pins and wearing a frame into a risk (according to the orthopedic surgeon's judgement)
Coagulation problems making occurrence of thrombosis or embolies into a risk (according to the orthopedic surgeon's judgement)
Existing endoprosthesis at any other joint (e.g. hip or contralateral knee) to prevent infection of existing prosthesis
History or presence of joint infection/inflammation
Hypersensitivity to antibiotics
Presence of systemic inflammatory disease, like rheumatoid arthritis

Treatment and study plan

Knee Joint Distraction (KD)

Procedure

Knee joint distraction (KJD) is a joint-preserving treatment for knee OA for younger patients, where the knee joint is temporarily fully unloaded by distraction of tibia and femur, using an external fixation frame.KJD treatment is performed according to the current approved concept NOV recommendations for clinical practice.

Knee Prosthesis

Procedure

A total or unicompartmental knee prosthesis

Primary outcomes

WOMAC total Score

Time frame: at 24 months

Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC) total score (scale 0-100, higher scores indicate improvement), with a non-inferiority limit of 15 points

Secondary outcomes

Health Related Quality of Life (HRQol)

Time frame: 24 months

SF36 physical component score and mental component score (0-100)

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for Young Knee Osteoarthritis Patients in Regular Care

Acronym: GODIVA

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Nov 2, 2023
Registry last updated: Nov 7, 2023

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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