Ergometer Cycling After Replacement of the Hip or Knee Joint

NCT ID: NCT00951990

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ergometer Cycling

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.

Intervention Type BEHAVIORAL

No ergometer cycling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V

OTHER

Sponsor Role collaborator

Landesversicherungsanstalt Schleswig-Holstein

UNKNOWN

Sponsor Role collaborator

Landesversicherungsanstalt Freie und Hansestadt Hamburg

UNKNOWN

Sponsor Role collaborator

Deutsche Arthrose-Hilfe

OTHER

Sponsor Role collaborator

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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University of Schleswig-Holstein Medical Center

Principal Investigators

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Joachim Hassenpflug, PhD

Role: STUDY_CHAIR

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

Locations

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Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery

Bad Bramstedt, , Germany

Site Status

Ostseeklinik Damp, Department I of Orthopedic Surgery

Damp, , Germany

Site Status

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

Kiel, , Germany

Site Status

University of Schleswig-Holstein Medical Center, Lübeck Campus

Lübeck, , Germany

Site Status

Wedel Hospital, Department of Surgery

Wedel, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24395308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23365035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21698485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23539698 (View on PubMed)

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.

Reference Type RESULT
PMID: 20360503 (View on PubMed)

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.

Reference Type RESULT
PMID: 26792619 (View on PubMed)

Other Identifiers

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vffr-37

Identifier Type: -

Identifier Source: org_study_id

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