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OsteoarthritisPhase 1/2NCT00951990

Ergometer Cycling After Replacement of the Hip or Knee Joint

A Phase 1/2 study testing Ergometer Cycling and No ergometer cycling in people with Osteoarthritis, run by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Ergometer Cycling and No ergometer cycling
How many people
457 participants
Where
5 sitesGermany
Study dates
Jan 2005to Aug 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery

    Bad Bramstedt, 24576

  • Ostseeklinik Damp, Department I of Orthopedic Surgery

    Damp, 24351

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

    Kiel, 24105

  • University of Schleswig-Holstein Medical Center, Lübeck Campus

    Lübeck, 23538

  • Wedel Hospital, Department of Surgery

    Wedel, 22880

Other trials in Germany

About this study

Official title: A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery

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
Being tested
Ergometer Cycling, No ergometer cycling
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ergometer CyclingBehavioural

    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 cyclingBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC Physical Function

    Measured: 3 months to 24 months

Secondary outcomes (4)

  1. WOMAC Pain and Stiffness

    Measured: 3 months to 24 months

  2. SF-36

    Measured: 3 months to 24 months

  3. Patient satisfaction

    Measured: 3 months to 24 months

  4. Lequesne Hip or Knee Score

    Measured: 3 months to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2009 (estimated)
  2. Study startJan 2005
  3. Primary completionApr 2006
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00951990
Sponsor's protocol ID
vffr-37
Status last verified
Apr 2016
First submitted
2 Aug 2009
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24395308

  • 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.

    PubMed 23365035

  • 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.

    PubMed 21698485

  • 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.

    PubMed 23539698

  • 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.

    PubMed 20360503

  • 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.

    PubMed 26792619

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ergometer Cycling and No ergometer cycling in people with Osteoarthritis, run by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC Physical Function (time frame: 3 months to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00951990, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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