Clinical trial NCT00951990: Ergometer Cycling After Replacement of the Hip or Knee Joint
Official title: A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Lead sponsor: Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V
name: Landesversicherungsanstalt Schleswig-Holstein
name: Landesversicherungsanstalt Freie und Hansestadt Hamburg
name: Deutsche Arthrose-Hilfe
First posted: 2009-08-04
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices.

In particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery.

Therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis of diagnosis of osteoarthritis or femoral head necrosis

Exclusion Criteria:

* A history of septic arthritis
* Hip fracture
* Intraoperative complications
* History of implant surgery on the joint to be operated on
* Rheumatoid arthritis
* Amputations
* Inability of complete the questionnaires because of cognitive or language difficulties

Primary outcomes:
measure: WOMAC Physical Function
timeFrame: 3 months to 24 months
Secondary outcomes:
measure: WOMAC Pain and Stiffness
timeFrame: 3 months to 24 months
measure: SF-36
timeFrame: 3 months to 24 months
measure: Patient satisfaction
timeFrame: 3 months to 24 months
measure: Lequesne Hip or Knee Score
timeFrame: 3 months to 24 months
Other outcomes:
Locations:
city: Bad Bramstedt
country: Germany
facility: Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery
city: Damp
country: Germany
facility: Ostseeklinik Damp, Department I of Orthopedic Surgery
city: Kiel
country: Germany
facility: University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein Medical Center, Lübeck Campus
city: Wedel
country: Germany
facility: Wedel Hospital, Department of Surgery
Study officials:
affiliation: University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery, Kiel Campus, 24105 Kiel, Germany
name: Joachim Hassenpflug, PhD
role: STUDY_CHAIR
References:
citation: Liebs TR, Nasser L, Herzberg W, Ruther W, Hassenpflug J. The influence of femoral offset on health-related quality of life after total hip replacement. Bone Joint J. 2014 Jan;96-B(1):36-42. doi: 10.1302/0301-620X.96B1.31530.
citation: Liebs TR, Herzberg W, Gluth J, Ruther W, Haasters J, Russlies M, Hassenpflug J. Using the patient's perspective to develop function short forms specific to total hip and knee replacement based on WOMAC function items. Bone Joint J. 2013 Feb;95-B(2):239-43. doi: 10.1302/0301-620X.95B2.28383.
citation: Liebs TR, Herzberg W, Roth-Kroeger AM, Ruther W, Hassenpflug J. Women recover faster than men after standard knee arthroplasty. Clin Orthop Relat Res. 2011 Oct;469(10):2855-65. doi: 10.1007/s11999-011-1921-z. Epub 2011 Jun 23.
citation: Liebs TR, Kloos SA, Herzberg W, Ruther W, Hassenpflug J. The significance of an asymmetric extension gap on routine radiographs after total knee replacement: A new sign and its clinical significance. Bone Joint J. 2013 Apr;95-B(4):472-7. doi: 10.1302/0301-620X.95B4.31080.
citation: Liebs TR, Herzberg W, Ruther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip or knee replacement surgery: a randomized controlled trial. J Bone Joint Surg Am. 2010 Apr;92(4):814-22. doi: 10.2106/JBJS.H.01359.
citation: Liebs TR, Herzberg W, Ruther W, Russlies M, Hassenpflug J; Multicenter Arthroplasty Aftercare Project, MAAP. Quality-Adjusted Life Years Gained by Hip and Knee Replacement Surgery and Its Aftercare. Arch Phys Med Rehabil. 2016 May;97(5):691-700. doi: 10.1016/j.apmr.2015.12.021. Epub 2016 Jan 11.