Ergometer Cycling After Replacement of the Hip or Knee Joint

NCT00951990 | Completed Phase 1 DMC

• 1 other identifier: vffr-37
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC Physical Function

  3 months to 24 months

Secondary Outcomes (4)

• WOMAC Pain and Stiffness

  3 months to 24 months

• SF-36

  3 months to 24 months

• Patient satisfaction

  3 months to 24 months

• Lequesne Hip or Knee Score

  3 months to 24 months

Interventions

Ergometer Cycling BEHAVIORAL

Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed three times a week for a time period of at least three weeks. The resistance of the ergometer was set to a minimum (for example 30 Watts). Physical therapists were informed to pay special attention, that the height of the saddle is set so that the forefoot reaches the pedal with the knee in extension.

No ergometer cycling BEHAVIORAL

Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein: lead
• Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V: collaborator
• Landesversicherungsanstalt Schleswig-Holstein: collaborator
• Landesversicherungsanstalt Freie und Hansestadt Hamburg: collaborator
• Deutsche Arthrose-Hilfe: collaborator

Study Sites (5)

Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery

Bad Bramstedt, 24576, Germany

Location

Ostseeklinik Damp, Department I of Orthopedic Surgery

Damp, 24351, Germany

Location

University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery

Kiel, 24105, Germany

Location

University of Schleswig-Holstein Medical Center, Lübeck Campus

Lübeck, 23538, Germany

Location

Wedel Hospital, Department of Surgery

Wedel, 22880, Germany

Location

Related Publications (6)

• 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.

  PMID: 24395308 BACKGROUND

• 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.

  PMID: 23365035 BACKGROUND

• 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.

  PMID: 21698485 BACKGROUND

• 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.

  PMID: 23539698 BACKGROUND

• 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.

  PMID: 20360503 RESULT

• 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.

  PMID: 26792619 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Joachim Hassenpflug, PhD

  University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery, Kiel Campus, 24105 Kiel, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2009
• First Posted: August 4, 2009
• Study Start: January 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: August 1, 2008
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DE (5)