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Rotator Cuff TearMOONNCT00762580

Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears

An observational study of Rotator Cuff Tear, run by Vanderbilt University at 9 sites in United States.

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

The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Rotator Cuff Tear
How many people
452 participants
Where
9 sitesUnited States
Study dates
Jan 2006to 11 Jan 2024
Phase
Observational
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults between the ages of 18-100 with full thickness rotator cuff tears.

Who may be able to join

  • Patients (18-100 years of age) with MRI findings of a full-thickness rotator cuff tear
  • Note: Criteria to obtain a shoulder MRI to evaluate for rotator cuff tear [Appendix D]:
  • Significant weakness (≥ 2 points per guidelines above.)
  • ADL pain or night pain >/= 7 on VAS
  • Significant impingement (per guidelines above) + with significant symptoms for ≥ 3 months.

Who cannot join

  • Acute rotator cuff tears (generally due to a high velocity injury and symptoms of less than one month)
  • Associated dislocations
  • Associated fractures
  • Systemic Rheumatologic disease, i.e. Rheumatoid Arthritis and Systemic Lupus Erythematosis
  • Patients being treated for bilateral rotator cuff tears simultaneously
  • Patients unable to complete the forms
Show all 13Show fewer
  • Pain from neck or scapula
  • Previous shoulder surgery
  • Glenohumeral arthritis (meets ≥ 1 of below criteria)
  • osteophytes >2mm on humeral head or glenoid
  • Joint space narrowing with sclerosis or cyst formation seen on true AP or axillary radiographs;
  • humeral head contacting acromion
  • Adhesive capsulitis

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Colorado University Sports Medicine

    Boulder, Colorado, 80304

  • Ohio State

    Columbus, Ohio, 43221-3502

  • Universtiy Of Iowa

    Iowa City, Iowa, 52242-1088

  • Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic

    Knoxville, Tennessee, 37922

  • Vanderbilt Universtiy Medical Center

    Nashville, Tennessee, 37232

  • Hospital for Special Surgery

    New York, New York, 10021

  • University of California at San Francisco

    San Francisco, California, 94143

  • Sports Medicine & Shoulder Surgery, Orthopedic Institute

    Sioux Falls, South Dakota, 57117

  • Department of Orthopaedic Surgery, Washington Universtiy School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears.

Read the detailed description

Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence increasing with age. While most people remain asymptomatic, it is unknown why some develop symptoms. In symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of patients, yet the majority of patients have a significant reduction pain despite failure of the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet it is not known which patient-related features predict success with nonoperative treatment. The general aim of this research effort is to identify patient features (historical information, physical examination findings, and MRI-based pathology) that would predict success (defined by reduction in visual analog pain scale, and patient satisfaction) with the nonoperative treatment of rotator cuff tears. The proposed study design is a prospective cohort study of patients with rotator cuff tears who will follow a standard physical therapy program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level 2 studies.

Study the effect of historical information on predicting success (as determined by pain relief and patient satisfaction) of nonoperative treatment using the EBM based physical therapy program in treating patients with rotator cuff tears.

Study the effect of physical examination findings on predicting success of a nonoperative treatment using the EBM-based physical therapy program in treating patients with rotator cuff tears.

Study the effect of the severity of the rotator cuff pathology (using standardized magnetic resonance imaging protocols) on predicting success of nonoperative treatment for patients with rotator cuff tears using the EBM-based physical therapy program.

Keywords
rotator cuff, rehabilitation
Medical subject headings
Rotator Cuff Injuries

What participants receive

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

Study groups in NCT00762580
Study groupRoleWhat they receive
ProspectivePatients with full thickness rotator cuff tears being treated with physical therapy

What is being measured

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

  1. Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.

    Measured: One year

Secondary outcomes (1)

  1. Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)

    Measured: One Year

Timeline

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

  1. First posted30 Sep 2008 (estimated)
  2. Study startJan 2006
  3. Primary completion11 Jan 2024
  4. Study completion11 Jan 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00762580
Sponsor's protocol ID
060109
Acronym
MOON
Status last verified
Jan 2024
First submitted
26 Sep 2008
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: De Identified data from this cohort is only available to members of the MOON Shoulder Consortium. The member must provide a description of the use of the data to the research coordinator. The data request is then presented to the MOON consortium. A unanimous agreement of the plan by the consortium must be received prior to receiving the data.

Publications

  • Bartolozzi A, Andreychik D, Ahmad S. Determinants of outcome in the treatment of rotator cuff disease. Clin Orthop Relat Res. 1994 Nov;(308):90-7.

    PubMed 7955708

  • Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.

    PubMed 8358901

  • Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum. 1991 Jun;34(6):766-9. doi: 10.1002/art.1780340619.

    PubMed 2053923

  • Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.

    PubMed 7722560

  • Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.

    PubMed 11741065

  • Ejnisman B, Andreoli CV, Soares BG, Fallopa F, Peccin MS, Abdalla RJ, Cohen M. Interventions for tears of the rotator cuff in adults. Cochrane Database Syst Rev. 2004;(1):CD002758. doi: 10.1002/14651858.CD002758.pub2.

    PubMed 14973989

  • Feng S, Guo S, Nobuhara K, Hashimoto J, Mimori K. Prognostic indicators for outcome following rotator cuff tear repair. J Orthop Surg (Hong Kong). 2003 Dec;11(2):110-6. doi: 10.1177/230949900301100202.

    PubMed 14676334

  • Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.

    PubMed 14960664

  • Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000 Apr;82(4):505-15. doi: 10.2106/00004623-200004000-00006.

    PubMed 10761941

  • Habernek H, Schmid L, Frauenschuh E. Five year results of rotator cuff repair. Br J Sports Med. 1999 Dec;33(6):430-3. doi: 10.1136/bjsm.33.6.430.

    PubMed 10597856

  • Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.

    PubMed 1874784

  • Hattrup SJ. Rotator cuff repair: relevance of patient age. J Shoulder Elbow Surg. 1995 Mar-Apr;4(2):95-100. doi: 10.1016/s1058-2746(05)80061-8.

    PubMed 7600171

  • Itoi E, Tabata S. Conservative treatment of rotator cuff tears. Clin Orthop Relat Res. 1992 Feb;(275):165-73.

    PubMed 1735208

  • Itoi E, Tabata S. Incomplete rotator cuff tears. Results of operative treatment. Clin Orthop Relat Res. 1992 Nov;(284):128-35.

    PubMed 1395281

  • Kim SH, Ha KI, Park JH, Kang JS, Oh SK, Oh I. Arthroscopic versus mini-open salvage repair of the rotator cuff tear: outcome analysis at 2 to 6 years' follow-up. Arthroscopy. 2003 Sep;19(7):746-54. doi: 10.1016/s0749-8063(03)00395-5.

    PubMed 12966383

Questions about this trial

What is this clinical trial studying?

An observational study of Rotator Cuff Tear, run by Vanderbilt University at 9 sites in United States.

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 5 inclusion and 13 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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.

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?

Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score. (time frame: One year). 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 NCT00762580, which also lists 51 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 16 Jan 2024.

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