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Author Verified
RCT
ACE Report #5680

Accelerated weight-bearing following MACI improves function and QoL


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Accelerated weightbearing rehabilitation after matrix-induced autologous chondrocyte implantation in the tibiofemoral joint: early clinical and radiological outcomes

Am J Sports Med. 2013 Oct;41(10):2314-24

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OE EXCLUSIVE

Dr. Ebert discusses how accelerated weightbearing rehabilitation can affect outcomes after matrix-induced autologous chondrocyte implantation.

Synopsis

A total of 26 patients (28 knees), who had undergone matrix-induced autologous chondrocyte implantation to treat full-thickness femoral condylar defects in the knee, were randomly assigned into 1 of 2 groups to test the effectiveness of an accelerated weight-bearing protocol following surgery. Patients either received a weight-bearing protocol that aimed to achieve maximum weight bearing by 6 weeks (accelerated) or 8 weeks. Results indicated that the accelerated weight-bearing protocol improved physical function and quality of life, and achieved earlier attainment of full active knee extension than conventional weight-bearing regimens.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Hollywood Private Hospital Research Foundation and the National Health and Medical Research Council
Conflicts:
None disclosed

Risk of Bias

7/10

Reporting Criteria

19/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Matrix-induced autologous chondrocyte implantation (MACI) is an effective way to repair full-thickness chondral defects in the knee. Successful cell culturing, efficiency of the surgical procedure, patient cooperation, and timely weight-bearing are all key factors that play a role in the effectiveness of treatment. Studies have proposed that more aggressive and accelerated weight-bearing rehabilitation following MACI for the tibiofemoral joint may be effective, but very little is known on this subject.

What was the principal research question?

What was the efficacy of an accelerated weight-bearing protocol following matrix-induced autologous chondrocyte implantation of a tibiofemoral joint, 12 months after surgery?

Study Characteristics -
Population:
A total of 26 patients (28 knees, due to operation on both knees in two patients), between the ages of 15 and 65, who had undergone MACI to treat full-thickness femoral condylar defects in the knee.
Intervention:
AR Group: Patients received a 2-stage MACI surgical technique which isolated and cultured the participants own cartilage cells, on a type I/III collagen membrane, in vitro and re-implanted them into the chondral defect through parapatellar mini-arthrotomy or through standard arthroscopic routine using anteromedial and anterolateral portals. Patients then were allocated to an accelerated weight bearing approach that allowed full weight-bearing 6 weeks after surgery. The approach maintained an initial 2-week 20% weight -bearing toe-touch phase, and subsequent load bearing until full weight-bearing was achieved at 6 weeks (Mean age: 34.5, n= 13, # of knees = 14, M=7/F=7).
Comparison:
CR Group: Patients received a 2-stage MACI surgical technique which isolated and cultured the participants own cartilage cells, on a type I/III collagen membrane, in vitro and re-implanted them into the chondral defect through parapatellar mini-arthrotomy or through standard arthroscopic routine using anteromedial and anterolateral portals. Patients were then allocated to a 2-week period of weight-bearing at 20% followed by a progressive increase until full weight-bearing was obtained 8 weeks after surgery completion (Mean age: 37.1, n= 13, # of knees=14, M=10/F=4).
Outcomes:
Outcomes assessed were: the Knee Injury and Osteoarthritis Scale (KOOS) to assess knee pain, symptoms, activities of daily life (ADL), sport and recreation, and knee-related quality of life, the Short form-36 (SF-36) to assess general health through mental and physical component scales (MCS and PCS, respectively), pain visual analog scale (VAS) to assess frequency and severity of knee pain, active knee flexion/extension, 3-repetition maximum straight-leg raise (3RM-SLR), absolute strength of both limbs, 6 minute walk test, and MRI-results.
Methods:
RCT: Single Center: Single blinded
Time:
12 months (Results were taken 4, 8, and 12 weeks, and 6 and 12 months after surgery).

What were the important findings?

  • Over the 12 month follow-up period, a significant time effect for all subjective clinical scores that showed improvement was found in each group (p<0.05). A significant group effect for the QOL subscales of the KOOS and a significant interaction effect for the PCS portion of the SF-36 and QOL subscale were also found in each group (p<0.05).
  • Post-hoc analysis comparing the two groups indicated significantly better SF-36 PCS scores in the AR group 8 weeks after surgery (p<0.05) and significantly better KOOS QOL scores at 6 and 12 month follow up (p<0.05).
  • During the 12 month follow-up, a significant time effect for active knee flexion and extension range of motion, 6 minute walking distance, and 3RM-SLR strength was found (p<0.05). The AR group was able to achieve full knee extension as early as 4 weeks compared to 12 weeks in the CR group.
  • A significant group effect was observed for 3RM-SLR strength, which indicated a lower strength discrepancy between operated and non-operated limbs in the AR group when compared to those in the CR group. No between group difference was found regarding 3RM-SLR (p>0.05).
  • MRI findings indicated a significant time effect for the MRI composite score, graft infill, signal intensity, border integration, and subchondral lamina during the follow-up period (p<0.05).
  • At final follow up (12 months), the degree of defect infill in the AR group was classified as very good (mean 3.57) compared to the CR group which had an average classification of good (mean 3.19).
  • 100% of AR patients showed good to excellent infill compared to 85% in the CR group. No reports of graft failure were reported in any group by final follow-up (12 months).

What should I remember most?

Patients in both groups experienced significant improvement in all clinical measures during the 12 month follow up. The AR group exhbited significantly better SF-36 PCS scores at 8 weeks and significantly better KOOS quality of life scores at 6 and 12 months postoperatively. No between group differences were found regarding active knee ROM. The AR group achieved full knee extension as early as 4 weeks compared to 12 weeks in the CR group. No difference was found between the groups regarding graft quality, and no side effects occurred due to the implants in either group.

How will this affect the care of my patients?

Results of this study indicated that an accelerated weight-bearing protocol following matrix-induced autologous chrondrocyte implantation of tibiofemoral joints may result in improved physical function and quality of life, along with earlier attainment of full active knee extension than conventional weight bearing regiment. No graft complications or adverse effects occurred due to accelerated weight bearing. Further research with longer follow up periods is required to validate the efficacy of this treatment.

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