Abstract
Knee joint distraction (KJD) has been evaluated as a joint-preserving treatment to postpone total knee arthroplasty in knee osteoarthritis patients in three clinical trials. Since 2014 the treatment is used in regular care in some hospitals, which might lead to a deviation from the original indication and decreased treatment outcome. In this study, baseline characteristics, complications and clinical benefit are compared between patients treated in regular care and in clinical trials. In our hospital, 84 patients were treated in regular care for 6 weeks with KJD. Surgical details, complications, and range of motion were assessed from patient hospital charts. Patient-reported outcome measures were evaluated in regular care before and one year after treatment. Trial patients (n = 62) were treated and followed as described in literature. Patient characteristics were not significantly different between groups, except for distraction duration (regular care 45.3±4.3; clinical trials 48.1±8.1 days; p = 0.019). Pin tract infections were the most occurring complication (70% regular care; 66% clinical trials), but there was no significant difference in treatment complications between groups (p>0.1). The range of motion was recovered within a year after treatment for both groups. WOMAC questionnaires showed statistically and clinically significant improvement for both groups (both p<0.001 and >15 points in all subscales) and no significant differences between groups (all differences p>0.05). After one year, 70% of patients were responders (regular care 61%, trial 75%; p = 0.120). Neither regular care compared to clinical trial, nor any other characteristic could predict clinical response. KJD as joint-preserving treatment in clinical practice, to postpone arthroplasty for end-stage knee osteoarthritis patient below the age of 65, results in an outcome similar to that thus far demonstrated in clinical trials. Longer follow-up in regular care is needed to test whether also long-term results remain beneficial and comparable to trial data.
Highlights
Knee osteoarthritis (OA) is characterized by articular cartilage degeneration and is an important cause of pain and disability in adults.[1,2] While total knee arthroplasty (TKA) is a widely accepted intervention for end-stage knee OA, it poses a major healthcare burden when placed in younger patients, since they have a higher risk of needing a costly and less effective revision surgery later in life.[3,4,5,6]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.[7]
Pin tract infections were the most occurring complication (70% regular care; 66% clinical trials), but there was no significant difference in treatment complications between groups (p>0.1)
Neither regular care compared to clinical trial, nor any other characteristic could predict clinical response
Summary
Knee osteoarthritis (OA) is characterized by articular cartilage degeneration and is an important cause of pain and disability in adults.[1,2] While total knee arthroplasty (TKA) is a widely accepted intervention for end-stage knee OA, it poses a major healthcare burden when placed in younger patients, since they have a higher risk of needing a costly and less effective revision surgery later in life.[3,4,5,6]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.[7]. In over three quarters of the patients, TKA could be postponed for over five years, and half of the patients was still without prosthesis nine years after treatment.[8,9,10,11] After this trial the distraction period was shortened to six weeks, as this was considered sufficient.[12] Between 2011 and 2014, the six-week KJD was studied in comparison to TKA or to high tibial osteotomy (HTO) in two separate randomized controlled trials (RCTs) In both trials combined, 41 KJD patients gained significant clinical and structural benefit in the first year, which was shown to be maintained up to at least two years after treatment. Both trials demonstrated that KJD was non-inferior to the alternative treatment.[13,14,15] Since 2014, KJD is offered as a regular care treatment in a limited number of hospitals for knee OA patients under the age of 65
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