Trial document




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  DRKS00003393

Trial Description

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Title

Preoperative strength and sensorimotor training prior to autologous chondrocyte implantation of the knee joint

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Trial Acronym

PREHACI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This project is to clarify whether preoperativ strength and sensorimotor training lead to a better postoperative outcome in patients with isolated cartilage defects of the knee joint that are planned to autologous chondrocyte implantation. In a first step, the amount of possible strength deficits in these patientis with cartilage defects of the knee joint need to be identified. The next step is to clarify whether the patients respond to preoperative strength and sensorimotor training despite of the cartilage damage and existing complaints. The main step is than to analyze the postoperative outcome in terms of clinical result, subjective satisfaction, muscle strength and neuromuscular control in the two randomized patient groups (intervention group with, control group without preoperative strength and sensomorimotor training).

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Brief Summary in Scientific Language

There are several studies suggesting that neuromuscular control and muscle strength is reduced in patients after autologous chondrocyte implantation (ACI) of the knee joint and that these deficits may be associated with a poorer medium to long-term clinical outcome. In a clinical study in our department of 52 patients four years after ACI, significant deficits in knee extensor strength and a reduced postural control have been detected (Kreuz et al., Am J Sports Med 2011). Reduced muscle strength after ACI despite a satisfactory clinical outcome was also shown by Loken et al. (Loken et al., Knee Surg Sports Traumatol Arthrosc 2009). Especially in the often young patients with cartilage defects of the knee, it appears to be particularly interesting that reduced strength capacity of the knee extensors can be considered as a primary risk factor for the progression of cartilage degeneration and knee osteoarthritis (Slemenda et al., Ann Intern Med 1997). It remains a matter of debate whether the observed deficits are primarily due to inadequate post-operative rehabilitation, or to pre-operative deficits and muscle atrophy. But as it must be expected those patients will have a poor outcome on the long term, strength deficits should not be tolerated.
It has to be clarified whether preoperatively existing strength deficit can positively be influenced by strength an ssensorimotor training. The main question to be answered than is whether patients that completed a preoperatiev strength training will have a more favorable outcome after the autologous chondrocyte implantation.
To answer this question, the study includs patients in whom ACI of the knee joint is scheduled. Patients will be randomly assigned to the "training group" or the "control group". The "training group" will complete 12 sessions of a standardized strength and sensorimotor training program during the four to six weeks in between cartilage biopsie and the implantation of the cultured cells. In parallel, they are instructed in the use of crutches and the postoperative treatment scheme. Patients in the "control group" will during the same waiting time only be instructed in the postoperative rehabilitation schematic and will learn to walk on crutches.
Group differences in muscle strength, postural control, subjective and objective clinical outcome will be tested at the end of the presurgical phase, as well as 6,12 and 24 month post surgery
Should the hypothesis be confirmed that the outcome of in patients performing strength training prior to surgery is better, the development of an osteoarthritis of the knee and the number of required re-operations could be reduced. In addition a relevant large group of patients would not need following surgery and wouldn´t have to suffer chronic pain. With this result not inconsiderable costs of health care can be saved.

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Organizational Data

  •   DRKS00003393
  •   2012/03/20
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  •   yes
  •   Approved
  •   355/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   M23.99 -  [generalization M23.9: Internal derangement of knee, unspecified]
  •   M94 -  Other disorders of cartilage
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Interventions/Observational Groups

  •   The "training group" will perform three sessions a week of strength and sensorimotor training during up to six weeks between the arthroscopic cartilage biopsie and the open knee surgery for the cell implantation. In parallel, they are instructed in the use of crutches and the postoperative treatment scheme.
  •   Patients in the "control group" are waiting the same time for the open surgery. They will be instructed in the postoperative treatment scheme, and learn to walk with crutches.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Functionality of the knee joint 12 months post-surgery (based on the validated "IKDC - international knee documentation" - 2000 Score (Brittberg et al, JBJS 2003, Niemeyer et al. Arthroscopy, 2010))

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Secondary Outcome

Pain on a visual analoge scale
Subjective clinical outcome (Lysholm score and KOOS score)
Functionality of the knee in activities of daily living (Chair Rise Test and Stair Climbing Test)
Isokinetic muscle strength of knee flexors and knee extensors (Contrex Multijoint System) and measurement of postural control (Posturomed) at the end of the training phase (Pre-OP) as well as six and twelve months post-operatively

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/06/15
  •   84
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

Patients with isolated symptomatic cartilage defect of the knee joint, planned autologues chondrocyte implantation and signed informed consent

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Exclusion Criteria

Instability of the knee joint, serious previous surgery, pre-existing neuromuscular conditions, compliance issues (e.g. patient lives too far away from rehabilitation center)

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Addresses

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    • Univertitätsklinikum Freiburg Department Orthopädie und Traumatologie
    • Mr.  Prof. Dr. med.  Norbert P.  Südkamp 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    •   0761 27026990
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    • Univertitätsklinikum Freiburg Department Orthopädie und Traumatologie
    • Ms.  Dr. med.  Anja  Hirschmüller 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Univertitätsklinikum Freiburg Department Orthopädie und Traumatologie
    • Ms.  Dr. med.  Anja  HIrschmüller 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Freiburg Department für Othopädie und Traumatologie
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.